Mastering ISO 13485: From Compliance to Competitive Advantage in Medical Devices
You’re under pressure. Regulatory deadlines are looming, and ISO 13485 compliance isn’t just a checkbox-it’s the foundation of your product’s market access, your company’s credibility, and your career’s trajectory. One audit finding could delay your launch. One process gap could cost millions. And if you’re not turning compliance into strategy, you’re leaving innovation and market share on the table. Most professionals learn ISO 13485 backwards-through fire drills, root cause analyses, and non-conformity reports. But the top performers don’t wait for audits to expose weaknesses. They design quality systems that don’t just pass inspection, they accelerate time-to-market, build investor trust, and differentiate in competitive tenders. That’s why this isn’t another theory-heavy compliance overview. This is Mastering ISO 13485: From Compliance to Competitive Advantage in Medical Devices-a precision-engineered professional development path that transforms your relationship with the standard. From confusion to clarity. From reactive checks to proactive advantage. This course delivers one dominant outcome: enabling you to design, implement, and lead an ISO 13485 quality management system that achieves certification faster, reduces annual compliance costs by up to 40%, and becomes a documented asset in funding rounds or M&A due diligence-all within 90 days of starting. Like Sarah Chen, Senior Quality Systems Engineer at a MedTech scale-up in Berlin. Before this course, her team spent 120+ hours preparing for their first ISO audit. After applying the risk-based documentation method taught here, they passed certification on the first attempt-with zero major findings-and cut documentation time in half. She told us: “This didn’t just save us time. It gave us leverage in our Series B. Investors saw our QMS as a competitive moat.” If you’re ready to shift from fearing audits to commanding them, from justifying QMS budgets to proving ROI, here’s how this course is structured to help you get there.Course Format & Delivery Details: Immediate Access, Zero Risk, Guaranteed Results Fully Self-Paced, On-Demand, and Designed for Real Professionals
This course is self-paced, with immediate online access upon enrollment confirmation. There are no fixed start dates, no live sessions to attend, and no time constraints. Whether you're in Tokyo, Toronto, or Tel Aviv, you control when and how you learn. On average, professionals complete the core curriculum in 6–8 weeks while working full time. Many apply the first risk assessment template within 72 hours of starting. Lifetime Access and Continuous Updates at No Extra Cost
Your investment includes lifetime access to all course materials. As ISO 13485 guidance evolves and regulatory expectations shift, we update the content proactively. You’ll always have access to the most current frameworks, tools, and best practices-no annual renewals, no hidden fees, no surprises. This is a permanent asset in your professional toolkit. Optimised for Global, Mobile-First Access
The course platform is mobile-friendly and accessible 24/7 across devices-laptop, tablet, or smartphone. Whether you're in a cleanroom, at an airport, or between meetings, your progress is saved and synchronised. You’ll benefit from progress tracking, searchable content, and downloadable tools designed for real-world application. Practical, Role-Focused Instructor Support
You’re not learning in isolation. This course includes direct access to instructor guidance through structured review pathways and expert-reviewed templates. While not a coaching program, every key concept is paired with implementation examples, and your submitted practice exercises receive detailed feedback based on real regulatory expectations. This ensures your work aligns with auditor expectations and industry benchmarks. Certificate of Completion: A Globally Recognised Credential
Upon successful completion, you’ll earn a Certificate of Completion issued by The Art of Service. This is not a generic participation badge. It is a verified credential recognised by employers, notified bodies, and regulatory consultants worldwide. Recipients consistently report increased visibility in promotion cycles, enhanced credibility during audits, and stronger positioning in competitive project bids. No Hidden Fees. Transparent, Simple Pricing.
The price you see is the price you pay. There are no upsells, no certification fees, no credit checks, and no recurring charges. Payment is a one-time, fully inclusive transaction. - Accepted payment methods: Visa, Mastercard, PayPal
Air-Tight, Zero-Risk Enrollment Guarantee
We understand the stakes. That’s why we offer a no-questions-asked money-back guarantee. If, within 30 days of receiving your access details, you find the course does not meet your expectations for professional impact, depth, or clarity, simply request a refund. You walk away with zero financial risk-and full access until you decide. Instant Confirmation, Hassle-Free Access
After enrollment, you’ll receive an immediate confirmation email. Your course access details will be sent separately once your enrolment is processed and course materials are ready. This ensures a smooth, error-free start with verified credentials and secure platform integration. “Will This Work for Me?” We Hear You-And Here’s Why It Will
Whether you’re a Quality Manager in a startup with five employees, a Regulatory Affairs Lead in a multinational, or an R&D Engineer newly tasked with documentation, this course is designed to scale to your context. The frameworks are modular, adaptable, and built on real submissions accepted by TÜV, BSI, and ANVISA. It works even if you’ve never led an ISO audit, even if your current QMS is fragmented, or even if you’re transitioning from a different regulatory environment like ISO 9001 or FDA 21 CFR Part 820. The step-by-step progression ensures foundational mastery before advancing to competitive application. This is not only for quality specialists. Engineering leads use it to design controls that satisfy both development velocity and compliance. CEOs use it to position their QMS as an investment, not a cost center. Consultants use it to deliver client-ready systems in half the time. This course doesn’t just teach the standard-it teaches you how to master it, lead from it, and win because of it.
Module 1: Foundations of ISO 13485 and the Medical Device Ecosystem - Understanding the global regulatory landscape for medical devices
- Key differences between ISO 13485, FDA QSR, MDR, and MDSAP
- Scope and applicability of ISO 13485 across device classes and markets
- Linking ISO 13485 to product safety, patient outcomes, and corporate liability
- How notified bodies and regulatory auditors interpret compliance
- Strategic importance of ISO 13485 in market access and tender submissions
- Mapping device lifecycle stages to QMS requirements
- Role of top management in quality policy and continual improvement
- Differences between ISO 9001 and ISO 13485: Medical device-specific clauses
- Using ISO 13485 as a foundation for global expansion
Module 2: Core Principles and Structure of a Medical Device QMS - Clause-by-clause walkthrough of ISO 13485:2016
- The seven principles of medical device quality management
- Documented information vs records: What must be retained and why
- Establishing quality objectives with measurable KPIs
- Developing a quality policy that aligns with business strategy
- Creating a documented organisational structure with clear roles
- Integrating risk management into quality policy and planning
- Resource planning: Personnel, infrastructure, and environmental controls
- Work environment requirements for sterile and non-sterile devices
- Contamination control and cleanliness validation protocols
Module 3: Process-Based Approach and Quality Planning - Mapping core business processes to ISO 13485 requirements
- Process flow diagrams for design, production, and post-market activities
- Process owners: Selection, training, and accountability frameworks
- Process performance metrics and trend analysis
- Quality planning documentation: PQPs and QAPs
- Planning for changes in device design or manufacturing
- Integrating CAPA into proactive quality planning
- Setting quality goals for new product introductions
- Process validation timing and documentation strategy
- Leveraging process maps during regulatory inspections
Module 4: Risk Management Integration (ISO 14971 Alignment) - Linking ISO 14971 and ISO 13485:2016 clause 4.1.3
- Risk management file structure and auditor expectations
- Establishing risk acceptance criteria approved by top management
- Hazard identification using HACCP, FMEA, and fault tree analysis
- Integrating risk into design, purchasing, and production controls
- Risk-benefit analysis documentation for submissions
- Post-market surveillance links to risk management reviews
- Maintaining a living risk file with version control
- Risk documentation required for Notified Body audits
- Common risk file findings and how to avoid them
Module 5: Document and Record Control Systems - Differentiating controlled documents vs records
- Document lifecycle: Creation, review, approval, and obsolescence
- Version control: Best practices for avoiding mix-ups
- Electronic document management system (EDMS) requirements
- Access control and user permissions for QMS documents
- Document retention periods aligned with regulatory timelines
- Archiving strategies for legacy and superseded documents
- Change control process for document revisions
- Ensuring availability of documents at point of use
- Training users on document control procedures
Module 6: Design and Development of Medical Devices - Design controls and stage-gate methodologies
- Establishing design inputs with traceable requirements
- Design input validation with clinical and user feedback
- Design outputs: Specifications, drawings, and BOMs
- Design review planning and cross-functional participation
- Design verification vs validation: Protocols and reports
- Design transfer: Ensuring manufacturing readiness
- Design changes: Impact assessment and re-validation
- Traceability matrix: Linking inputs, outputs, and testing
- Design freeze and configuration management
Module 7: Supplier and Purchasing Controls - Supplier evaluation and risk-based qualification
- Developing supplier scorecards and KPIs
- Managing single-source and critical suppliers
- Purchasing information: Specifications, quality agreements
- Supplier audit planning and execution
- Acceptance of raw materials and components
- Handling non-conforming supplier products
- Monitoring supplier performance trends
- Managing outsourced processes and contract manufacturers
- Regulatory requirements for supplier records retention
Module 8: Production and Process Controls - Production planning and scheduling under quality constraints
- Work instructions: Clarity, accessibility, and training
- Line clearance and changeover verification
- Identification and traceability: UDI, lot, and serial numbers
- Contamination prevention in production environments
- Process validation: Installation, Operational, and Performance Qualification
- Process monitoring tools: SPC and control charts
- Calibration and maintenance of production equipment
- Handling and storage: Preventing damage and degradation
- Packaging, labelling, and sterilisation controls
Module 9: Inspection, Testing, and Acceptance of Devices - Incoming, in-process, and final inspection protocols
- Test method validation and measurement system analysis
- Selecting critical-to-quality (CTQ) parameters
- Sampling plans: AQL, zero-defect, and risk-based approaches
- Maintaining calibrated inspection and test equipment
- Test record retention and data integrity requirements
- Outsourcing testing: Oversight and audit requirements
- Software validation for automated test systems
- Batch record review and final release procedures
- Handling rejected devices: Quarantine and disposition
Module 10: Non-Conforming Product Management - Detection and documentation of non-conformities
- Segregation and quarantine procedures
- Immediate containment actions
- Disposition options: Re-work, scrap, concession, use-as-is
- Regulatory reporting triggers for non-conforming devices
- Linking non-conformities to CAPA and risk management
- Customer communication protocols for recalls
- Managing field corrections and advisory notices
- Auditor focus on non-conformity data trends
- Metrics for non-conformance rate and cost of poor quality
Module 11: Corrective and Preventive Action (CAPA) - Distinguishing corrective, preventive, and improvement actions
- CAPA initiation triggers: Audits, complaints, NCRs
- Root cause analysis tools: 5 Whys, Fishbone, Pareto
- Effective corrective action: Timeliness and verification
- Preventive actions based on risk and trend data
- CAPA workflow: Tracking, escalation, and closure
- Auditor scrutiny of closed-loop effectiveness
- Metrics: CAPA cycle time, recurrence rate, backlog
- Linking CAPA to management review and continual improvement
- Common CAPA findings and how to avoid them
Module 12: Feedback, Complaints, and Post-Market Surveillance - Establishing complaint handling procedures
- Complaint triage: Valid, suspect, device-related
- Required complaint record elements
- Investigation timelines and regulatory reporting
- Linking complaints to CAPA and field actions
- Post-market surveillance planning and data collection
- Benefit-risk monitoring and periodic safety reports
- Looking for signals in complaint trend analysis
- Feedback from distributors, clinicians, and patients
- Using feedback to inform design improvements
Module 13: Internal Audits and Management Review - Internal audit program planning and scheduling
- Selecting and training internal auditors
- Conducting process-based audit interviews
- Writing clear, evidence-based audit findings
- Presenting audit results to management
- Follow-up on audit corrective actions
- Management review inputs: Performance, compliance, risks
- Management review outputs: Action plans, resource decisions
- Documenting management review meetings
- Auditor expectations for management engagement
Module 14: Preparation for Certification and Surveillance Audits - Selecting a notified body or registrar
- Stage 1 vs Stage 2 audit expectations
- Gathering and organising audit evidence
- Preparing the facility: Documentation, personnel, records
- Conducting mock audits and gap assessments
- Handling auditor questions and requests
- Responding to non-conformities during audits
- Developing audit response and action plans
- Surveillance audit readiness checklist
- Becoming audit-ready: Maintaining a state of continual compliance
Module 15: Leveraging ISO 13485 for Competitive Advantage - Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Understanding the global regulatory landscape for medical devices
- Key differences between ISO 13485, FDA QSR, MDR, and MDSAP
- Scope and applicability of ISO 13485 across device classes and markets
- Linking ISO 13485 to product safety, patient outcomes, and corporate liability
- How notified bodies and regulatory auditors interpret compliance
- Strategic importance of ISO 13485 in market access and tender submissions
- Mapping device lifecycle stages to QMS requirements
- Role of top management in quality policy and continual improvement
- Differences between ISO 9001 and ISO 13485: Medical device-specific clauses
- Using ISO 13485 as a foundation for global expansion
Module 2: Core Principles and Structure of a Medical Device QMS - Clause-by-clause walkthrough of ISO 13485:2016
- The seven principles of medical device quality management
- Documented information vs records: What must be retained and why
- Establishing quality objectives with measurable KPIs
- Developing a quality policy that aligns with business strategy
- Creating a documented organisational structure with clear roles
- Integrating risk management into quality policy and planning
- Resource planning: Personnel, infrastructure, and environmental controls
- Work environment requirements for sterile and non-sterile devices
- Contamination control and cleanliness validation protocols
Module 3: Process-Based Approach and Quality Planning - Mapping core business processes to ISO 13485 requirements
- Process flow diagrams for design, production, and post-market activities
- Process owners: Selection, training, and accountability frameworks
- Process performance metrics and trend analysis
- Quality planning documentation: PQPs and QAPs
- Planning for changes in device design or manufacturing
- Integrating CAPA into proactive quality planning
- Setting quality goals for new product introductions
- Process validation timing and documentation strategy
- Leveraging process maps during regulatory inspections
Module 4: Risk Management Integration (ISO 14971 Alignment) - Linking ISO 14971 and ISO 13485:2016 clause 4.1.3
- Risk management file structure and auditor expectations
- Establishing risk acceptance criteria approved by top management
- Hazard identification using HACCP, FMEA, and fault tree analysis
- Integrating risk into design, purchasing, and production controls
- Risk-benefit analysis documentation for submissions
- Post-market surveillance links to risk management reviews
- Maintaining a living risk file with version control
- Risk documentation required for Notified Body audits
- Common risk file findings and how to avoid them
Module 5: Document and Record Control Systems - Differentiating controlled documents vs records
- Document lifecycle: Creation, review, approval, and obsolescence
- Version control: Best practices for avoiding mix-ups
- Electronic document management system (EDMS) requirements
- Access control and user permissions for QMS documents
- Document retention periods aligned with regulatory timelines
- Archiving strategies for legacy and superseded documents
- Change control process for document revisions
- Ensuring availability of documents at point of use
- Training users on document control procedures
Module 6: Design and Development of Medical Devices - Design controls and stage-gate methodologies
- Establishing design inputs with traceable requirements
- Design input validation with clinical and user feedback
- Design outputs: Specifications, drawings, and BOMs
- Design review planning and cross-functional participation
- Design verification vs validation: Protocols and reports
- Design transfer: Ensuring manufacturing readiness
- Design changes: Impact assessment and re-validation
- Traceability matrix: Linking inputs, outputs, and testing
- Design freeze and configuration management
Module 7: Supplier and Purchasing Controls - Supplier evaluation and risk-based qualification
- Developing supplier scorecards and KPIs
- Managing single-source and critical suppliers
- Purchasing information: Specifications, quality agreements
- Supplier audit planning and execution
- Acceptance of raw materials and components
- Handling non-conforming supplier products
- Monitoring supplier performance trends
- Managing outsourced processes and contract manufacturers
- Regulatory requirements for supplier records retention
Module 8: Production and Process Controls - Production planning and scheduling under quality constraints
- Work instructions: Clarity, accessibility, and training
- Line clearance and changeover verification
- Identification and traceability: UDI, lot, and serial numbers
- Contamination prevention in production environments
- Process validation: Installation, Operational, and Performance Qualification
- Process monitoring tools: SPC and control charts
- Calibration and maintenance of production equipment
- Handling and storage: Preventing damage and degradation
- Packaging, labelling, and sterilisation controls
Module 9: Inspection, Testing, and Acceptance of Devices - Incoming, in-process, and final inspection protocols
- Test method validation and measurement system analysis
- Selecting critical-to-quality (CTQ) parameters
- Sampling plans: AQL, zero-defect, and risk-based approaches
- Maintaining calibrated inspection and test equipment
- Test record retention and data integrity requirements
- Outsourcing testing: Oversight and audit requirements
- Software validation for automated test systems
- Batch record review and final release procedures
- Handling rejected devices: Quarantine and disposition
Module 10: Non-Conforming Product Management - Detection and documentation of non-conformities
- Segregation and quarantine procedures
- Immediate containment actions
- Disposition options: Re-work, scrap, concession, use-as-is
- Regulatory reporting triggers for non-conforming devices
- Linking non-conformities to CAPA and risk management
- Customer communication protocols for recalls
- Managing field corrections and advisory notices
- Auditor focus on non-conformity data trends
- Metrics for non-conformance rate and cost of poor quality
Module 11: Corrective and Preventive Action (CAPA) - Distinguishing corrective, preventive, and improvement actions
- CAPA initiation triggers: Audits, complaints, NCRs
- Root cause analysis tools: 5 Whys, Fishbone, Pareto
- Effective corrective action: Timeliness and verification
- Preventive actions based on risk and trend data
- CAPA workflow: Tracking, escalation, and closure
- Auditor scrutiny of closed-loop effectiveness
- Metrics: CAPA cycle time, recurrence rate, backlog
- Linking CAPA to management review and continual improvement
- Common CAPA findings and how to avoid them
Module 12: Feedback, Complaints, and Post-Market Surveillance - Establishing complaint handling procedures
- Complaint triage: Valid, suspect, device-related
- Required complaint record elements
- Investigation timelines and regulatory reporting
- Linking complaints to CAPA and field actions
- Post-market surveillance planning and data collection
- Benefit-risk monitoring and periodic safety reports
- Looking for signals in complaint trend analysis
- Feedback from distributors, clinicians, and patients
- Using feedback to inform design improvements
Module 13: Internal Audits and Management Review - Internal audit program planning and scheduling
- Selecting and training internal auditors
- Conducting process-based audit interviews
- Writing clear, evidence-based audit findings
- Presenting audit results to management
- Follow-up on audit corrective actions
- Management review inputs: Performance, compliance, risks
- Management review outputs: Action plans, resource decisions
- Documenting management review meetings
- Auditor expectations for management engagement
Module 14: Preparation for Certification and Surveillance Audits - Selecting a notified body or registrar
- Stage 1 vs Stage 2 audit expectations
- Gathering and organising audit evidence
- Preparing the facility: Documentation, personnel, records
- Conducting mock audits and gap assessments
- Handling auditor questions and requests
- Responding to non-conformities during audits
- Developing audit response and action plans
- Surveillance audit readiness checklist
- Becoming audit-ready: Maintaining a state of continual compliance
Module 15: Leveraging ISO 13485 for Competitive Advantage - Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Mapping core business processes to ISO 13485 requirements
- Process flow diagrams for design, production, and post-market activities
- Process owners: Selection, training, and accountability frameworks
- Process performance metrics and trend analysis
- Quality planning documentation: PQPs and QAPs
- Planning for changes in device design or manufacturing
- Integrating CAPA into proactive quality planning
- Setting quality goals for new product introductions
- Process validation timing and documentation strategy
- Leveraging process maps during regulatory inspections
Module 4: Risk Management Integration (ISO 14971 Alignment) - Linking ISO 14971 and ISO 13485:2016 clause 4.1.3
- Risk management file structure and auditor expectations
- Establishing risk acceptance criteria approved by top management
- Hazard identification using HACCP, FMEA, and fault tree analysis
- Integrating risk into design, purchasing, and production controls
- Risk-benefit analysis documentation for submissions
- Post-market surveillance links to risk management reviews
- Maintaining a living risk file with version control
- Risk documentation required for Notified Body audits
- Common risk file findings and how to avoid them
Module 5: Document and Record Control Systems - Differentiating controlled documents vs records
- Document lifecycle: Creation, review, approval, and obsolescence
- Version control: Best practices for avoiding mix-ups
- Electronic document management system (EDMS) requirements
- Access control and user permissions for QMS documents
- Document retention periods aligned with regulatory timelines
- Archiving strategies for legacy and superseded documents
- Change control process for document revisions
- Ensuring availability of documents at point of use
- Training users on document control procedures
Module 6: Design and Development of Medical Devices - Design controls and stage-gate methodologies
- Establishing design inputs with traceable requirements
- Design input validation with clinical and user feedback
- Design outputs: Specifications, drawings, and BOMs
- Design review planning and cross-functional participation
- Design verification vs validation: Protocols and reports
- Design transfer: Ensuring manufacturing readiness
- Design changes: Impact assessment and re-validation
- Traceability matrix: Linking inputs, outputs, and testing
- Design freeze and configuration management
Module 7: Supplier and Purchasing Controls - Supplier evaluation and risk-based qualification
- Developing supplier scorecards and KPIs
- Managing single-source and critical suppliers
- Purchasing information: Specifications, quality agreements
- Supplier audit planning and execution
- Acceptance of raw materials and components
- Handling non-conforming supplier products
- Monitoring supplier performance trends
- Managing outsourced processes and contract manufacturers
- Regulatory requirements for supplier records retention
Module 8: Production and Process Controls - Production planning and scheduling under quality constraints
- Work instructions: Clarity, accessibility, and training
- Line clearance and changeover verification
- Identification and traceability: UDI, lot, and serial numbers
- Contamination prevention in production environments
- Process validation: Installation, Operational, and Performance Qualification
- Process monitoring tools: SPC and control charts
- Calibration and maintenance of production equipment
- Handling and storage: Preventing damage and degradation
- Packaging, labelling, and sterilisation controls
Module 9: Inspection, Testing, and Acceptance of Devices - Incoming, in-process, and final inspection protocols
- Test method validation and measurement system analysis
- Selecting critical-to-quality (CTQ) parameters
- Sampling plans: AQL, zero-defect, and risk-based approaches
- Maintaining calibrated inspection and test equipment
- Test record retention and data integrity requirements
- Outsourcing testing: Oversight and audit requirements
- Software validation for automated test systems
- Batch record review and final release procedures
- Handling rejected devices: Quarantine and disposition
Module 10: Non-Conforming Product Management - Detection and documentation of non-conformities
- Segregation and quarantine procedures
- Immediate containment actions
- Disposition options: Re-work, scrap, concession, use-as-is
- Regulatory reporting triggers for non-conforming devices
- Linking non-conformities to CAPA and risk management
- Customer communication protocols for recalls
- Managing field corrections and advisory notices
- Auditor focus on non-conformity data trends
- Metrics for non-conformance rate and cost of poor quality
Module 11: Corrective and Preventive Action (CAPA) - Distinguishing corrective, preventive, and improvement actions
- CAPA initiation triggers: Audits, complaints, NCRs
- Root cause analysis tools: 5 Whys, Fishbone, Pareto
- Effective corrective action: Timeliness and verification
- Preventive actions based on risk and trend data
- CAPA workflow: Tracking, escalation, and closure
- Auditor scrutiny of closed-loop effectiveness
- Metrics: CAPA cycle time, recurrence rate, backlog
- Linking CAPA to management review and continual improvement
- Common CAPA findings and how to avoid them
Module 12: Feedback, Complaints, and Post-Market Surveillance - Establishing complaint handling procedures
- Complaint triage: Valid, suspect, device-related
- Required complaint record elements
- Investigation timelines and regulatory reporting
- Linking complaints to CAPA and field actions
- Post-market surveillance planning and data collection
- Benefit-risk monitoring and periodic safety reports
- Looking for signals in complaint trend analysis
- Feedback from distributors, clinicians, and patients
- Using feedback to inform design improvements
Module 13: Internal Audits and Management Review - Internal audit program planning and scheduling
- Selecting and training internal auditors
- Conducting process-based audit interviews
- Writing clear, evidence-based audit findings
- Presenting audit results to management
- Follow-up on audit corrective actions
- Management review inputs: Performance, compliance, risks
- Management review outputs: Action plans, resource decisions
- Documenting management review meetings
- Auditor expectations for management engagement
Module 14: Preparation for Certification and Surveillance Audits - Selecting a notified body or registrar
- Stage 1 vs Stage 2 audit expectations
- Gathering and organising audit evidence
- Preparing the facility: Documentation, personnel, records
- Conducting mock audits and gap assessments
- Handling auditor questions and requests
- Responding to non-conformities during audits
- Developing audit response and action plans
- Surveillance audit readiness checklist
- Becoming audit-ready: Maintaining a state of continual compliance
Module 15: Leveraging ISO 13485 for Competitive Advantage - Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Differentiating controlled documents vs records
- Document lifecycle: Creation, review, approval, and obsolescence
- Version control: Best practices for avoiding mix-ups
- Electronic document management system (EDMS) requirements
- Access control and user permissions for QMS documents
- Document retention periods aligned with regulatory timelines
- Archiving strategies for legacy and superseded documents
- Change control process for document revisions
- Ensuring availability of documents at point of use
- Training users on document control procedures
Module 6: Design and Development of Medical Devices - Design controls and stage-gate methodologies
- Establishing design inputs with traceable requirements
- Design input validation with clinical and user feedback
- Design outputs: Specifications, drawings, and BOMs
- Design review planning and cross-functional participation
- Design verification vs validation: Protocols and reports
- Design transfer: Ensuring manufacturing readiness
- Design changes: Impact assessment and re-validation
- Traceability matrix: Linking inputs, outputs, and testing
- Design freeze and configuration management
Module 7: Supplier and Purchasing Controls - Supplier evaluation and risk-based qualification
- Developing supplier scorecards and KPIs
- Managing single-source and critical suppliers
- Purchasing information: Specifications, quality agreements
- Supplier audit planning and execution
- Acceptance of raw materials and components
- Handling non-conforming supplier products
- Monitoring supplier performance trends
- Managing outsourced processes and contract manufacturers
- Regulatory requirements for supplier records retention
Module 8: Production and Process Controls - Production planning and scheduling under quality constraints
- Work instructions: Clarity, accessibility, and training
- Line clearance and changeover verification
- Identification and traceability: UDI, lot, and serial numbers
- Contamination prevention in production environments
- Process validation: Installation, Operational, and Performance Qualification
- Process monitoring tools: SPC and control charts
- Calibration and maintenance of production equipment
- Handling and storage: Preventing damage and degradation
- Packaging, labelling, and sterilisation controls
Module 9: Inspection, Testing, and Acceptance of Devices - Incoming, in-process, and final inspection protocols
- Test method validation and measurement system analysis
- Selecting critical-to-quality (CTQ) parameters
- Sampling plans: AQL, zero-defect, and risk-based approaches
- Maintaining calibrated inspection and test equipment
- Test record retention and data integrity requirements
- Outsourcing testing: Oversight and audit requirements
- Software validation for automated test systems
- Batch record review and final release procedures
- Handling rejected devices: Quarantine and disposition
Module 10: Non-Conforming Product Management - Detection and documentation of non-conformities
- Segregation and quarantine procedures
- Immediate containment actions
- Disposition options: Re-work, scrap, concession, use-as-is
- Regulatory reporting triggers for non-conforming devices
- Linking non-conformities to CAPA and risk management
- Customer communication protocols for recalls
- Managing field corrections and advisory notices
- Auditor focus on non-conformity data trends
- Metrics for non-conformance rate and cost of poor quality
Module 11: Corrective and Preventive Action (CAPA) - Distinguishing corrective, preventive, and improvement actions
- CAPA initiation triggers: Audits, complaints, NCRs
- Root cause analysis tools: 5 Whys, Fishbone, Pareto
- Effective corrective action: Timeliness and verification
- Preventive actions based on risk and trend data
- CAPA workflow: Tracking, escalation, and closure
- Auditor scrutiny of closed-loop effectiveness
- Metrics: CAPA cycle time, recurrence rate, backlog
- Linking CAPA to management review and continual improvement
- Common CAPA findings and how to avoid them
Module 12: Feedback, Complaints, and Post-Market Surveillance - Establishing complaint handling procedures
- Complaint triage: Valid, suspect, device-related
- Required complaint record elements
- Investigation timelines and regulatory reporting
- Linking complaints to CAPA and field actions
- Post-market surveillance planning and data collection
- Benefit-risk monitoring and periodic safety reports
- Looking for signals in complaint trend analysis
- Feedback from distributors, clinicians, and patients
- Using feedback to inform design improvements
Module 13: Internal Audits and Management Review - Internal audit program planning and scheduling
- Selecting and training internal auditors
- Conducting process-based audit interviews
- Writing clear, evidence-based audit findings
- Presenting audit results to management
- Follow-up on audit corrective actions
- Management review inputs: Performance, compliance, risks
- Management review outputs: Action plans, resource decisions
- Documenting management review meetings
- Auditor expectations for management engagement
Module 14: Preparation for Certification and Surveillance Audits - Selecting a notified body or registrar
- Stage 1 vs Stage 2 audit expectations
- Gathering and organising audit evidence
- Preparing the facility: Documentation, personnel, records
- Conducting mock audits and gap assessments
- Handling auditor questions and requests
- Responding to non-conformities during audits
- Developing audit response and action plans
- Surveillance audit readiness checklist
- Becoming audit-ready: Maintaining a state of continual compliance
Module 15: Leveraging ISO 13485 for Competitive Advantage - Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Supplier evaluation and risk-based qualification
- Developing supplier scorecards and KPIs
- Managing single-source and critical suppliers
- Purchasing information: Specifications, quality agreements
- Supplier audit planning and execution
- Acceptance of raw materials and components
- Handling non-conforming supplier products
- Monitoring supplier performance trends
- Managing outsourced processes and contract manufacturers
- Regulatory requirements for supplier records retention
Module 8: Production and Process Controls - Production planning and scheduling under quality constraints
- Work instructions: Clarity, accessibility, and training
- Line clearance and changeover verification
- Identification and traceability: UDI, lot, and serial numbers
- Contamination prevention in production environments
- Process validation: Installation, Operational, and Performance Qualification
- Process monitoring tools: SPC and control charts
- Calibration and maintenance of production equipment
- Handling and storage: Preventing damage and degradation
- Packaging, labelling, and sterilisation controls
Module 9: Inspection, Testing, and Acceptance of Devices - Incoming, in-process, and final inspection protocols
- Test method validation and measurement system analysis
- Selecting critical-to-quality (CTQ) parameters
- Sampling plans: AQL, zero-defect, and risk-based approaches
- Maintaining calibrated inspection and test equipment
- Test record retention and data integrity requirements
- Outsourcing testing: Oversight and audit requirements
- Software validation for automated test systems
- Batch record review and final release procedures
- Handling rejected devices: Quarantine and disposition
Module 10: Non-Conforming Product Management - Detection and documentation of non-conformities
- Segregation and quarantine procedures
- Immediate containment actions
- Disposition options: Re-work, scrap, concession, use-as-is
- Regulatory reporting triggers for non-conforming devices
- Linking non-conformities to CAPA and risk management
- Customer communication protocols for recalls
- Managing field corrections and advisory notices
- Auditor focus on non-conformity data trends
- Metrics for non-conformance rate and cost of poor quality
Module 11: Corrective and Preventive Action (CAPA) - Distinguishing corrective, preventive, and improvement actions
- CAPA initiation triggers: Audits, complaints, NCRs
- Root cause analysis tools: 5 Whys, Fishbone, Pareto
- Effective corrective action: Timeliness and verification
- Preventive actions based on risk and trend data
- CAPA workflow: Tracking, escalation, and closure
- Auditor scrutiny of closed-loop effectiveness
- Metrics: CAPA cycle time, recurrence rate, backlog
- Linking CAPA to management review and continual improvement
- Common CAPA findings and how to avoid them
Module 12: Feedback, Complaints, and Post-Market Surveillance - Establishing complaint handling procedures
- Complaint triage: Valid, suspect, device-related
- Required complaint record elements
- Investigation timelines and regulatory reporting
- Linking complaints to CAPA and field actions
- Post-market surveillance planning and data collection
- Benefit-risk monitoring and periodic safety reports
- Looking for signals in complaint trend analysis
- Feedback from distributors, clinicians, and patients
- Using feedback to inform design improvements
Module 13: Internal Audits and Management Review - Internal audit program planning and scheduling
- Selecting and training internal auditors
- Conducting process-based audit interviews
- Writing clear, evidence-based audit findings
- Presenting audit results to management
- Follow-up on audit corrective actions
- Management review inputs: Performance, compliance, risks
- Management review outputs: Action plans, resource decisions
- Documenting management review meetings
- Auditor expectations for management engagement
Module 14: Preparation for Certification and Surveillance Audits - Selecting a notified body or registrar
- Stage 1 vs Stage 2 audit expectations
- Gathering and organising audit evidence
- Preparing the facility: Documentation, personnel, records
- Conducting mock audits and gap assessments
- Handling auditor questions and requests
- Responding to non-conformities during audits
- Developing audit response and action plans
- Surveillance audit readiness checklist
- Becoming audit-ready: Maintaining a state of continual compliance
Module 15: Leveraging ISO 13485 for Competitive Advantage - Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Incoming, in-process, and final inspection protocols
- Test method validation and measurement system analysis
- Selecting critical-to-quality (CTQ) parameters
- Sampling plans: AQL, zero-defect, and risk-based approaches
- Maintaining calibrated inspection and test equipment
- Test record retention and data integrity requirements
- Outsourcing testing: Oversight and audit requirements
- Software validation for automated test systems
- Batch record review and final release procedures
- Handling rejected devices: Quarantine and disposition
Module 10: Non-Conforming Product Management - Detection and documentation of non-conformities
- Segregation and quarantine procedures
- Immediate containment actions
- Disposition options: Re-work, scrap, concession, use-as-is
- Regulatory reporting triggers for non-conforming devices
- Linking non-conformities to CAPA and risk management
- Customer communication protocols for recalls
- Managing field corrections and advisory notices
- Auditor focus on non-conformity data trends
- Metrics for non-conformance rate and cost of poor quality
Module 11: Corrective and Preventive Action (CAPA) - Distinguishing corrective, preventive, and improvement actions
- CAPA initiation triggers: Audits, complaints, NCRs
- Root cause analysis tools: 5 Whys, Fishbone, Pareto
- Effective corrective action: Timeliness and verification
- Preventive actions based on risk and trend data
- CAPA workflow: Tracking, escalation, and closure
- Auditor scrutiny of closed-loop effectiveness
- Metrics: CAPA cycle time, recurrence rate, backlog
- Linking CAPA to management review and continual improvement
- Common CAPA findings and how to avoid them
Module 12: Feedback, Complaints, and Post-Market Surveillance - Establishing complaint handling procedures
- Complaint triage: Valid, suspect, device-related
- Required complaint record elements
- Investigation timelines and regulatory reporting
- Linking complaints to CAPA and field actions
- Post-market surveillance planning and data collection
- Benefit-risk monitoring and periodic safety reports
- Looking for signals in complaint trend analysis
- Feedback from distributors, clinicians, and patients
- Using feedback to inform design improvements
Module 13: Internal Audits and Management Review - Internal audit program planning and scheduling
- Selecting and training internal auditors
- Conducting process-based audit interviews
- Writing clear, evidence-based audit findings
- Presenting audit results to management
- Follow-up on audit corrective actions
- Management review inputs: Performance, compliance, risks
- Management review outputs: Action plans, resource decisions
- Documenting management review meetings
- Auditor expectations for management engagement
Module 14: Preparation for Certification and Surveillance Audits - Selecting a notified body or registrar
- Stage 1 vs Stage 2 audit expectations
- Gathering and organising audit evidence
- Preparing the facility: Documentation, personnel, records
- Conducting mock audits and gap assessments
- Handling auditor questions and requests
- Responding to non-conformities during audits
- Developing audit response and action plans
- Surveillance audit readiness checklist
- Becoming audit-ready: Maintaining a state of continual compliance
Module 15: Leveraging ISO 13485 for Competitive Advantage - Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Distinguishing corrective, preventive, and improvement actions
- CAPA initiation triggers: Audits, complaints, NCRs
- Root cause analysis tools: 5 Whys, Fishbone, Pareto
- Effective corrective action: Timeliness and verification
- Preventive actions based on risk and trend data
- CAPA workflow: Tracking, escalation, and closure
- Auditor scrutiny of closed-loop effectiveness
- Metrics: CAPA cycle time, recurrence rate, backlog
- Linking CAPA to management review and continual improvement
- Common CAPA findings and how to avoid them
Module 12: Feedback, Complaints, and Post-Market Surveillance - Establishing complaint handling procedures
- Complaint triage: Valid, suspect, device-related
- Required complaint record elements
- Investigation timelines and regulatory reporting
- Linking complaints to CAPA and field actions
- Post-market surveillance planning and data collection
- Benefit-risk monitoring and periodic safety reports
- Looking for signals in complaint trend analysis
- Feedback from distributors, clinicians, and patients
- Using feedback to inform design improvements
Module 13: Internal Audits and Management Review - Internal audit program planning and scheduling
- Selecting and training internal auditors
- Conducting process-based audit interviews
- Writing clear, evidence-based audit findings
- Presenting audit results to management
- Follow-up on audit corrective actions
- Management review inputs: Performance, compliance, risks
- Management review outputs: Action plans, resource decisions
- Documenting management review meetings
- Auditor expectations for management engagement
Module 14: Preparation for Certification and Surveillance Audits - Selecting a notified body or registrar
- Stage 1 vs Stage 2 audit expectations
- Gathering and organising audit evidence
- Preparing the facility: Documentation, personnel, records
- Conducting mock audits and gap assessments
- Handling auditor questions and requests
- Responding to non-conformities during audits
- Developing audit response and action plans
- Surveillance audit readiness checklist
- Becoming audit-ready: Maintaining a state of continual compliance
Module 15: Leveraging ISO 13485 for Competitive Advantage - Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Internal audit program planning and scheduling
- Selecting and training internal auditors
- Conducting process-based audit interviews
- Writing clear, evidence-based audit findings
- Presenting audit results to management
- Follow-up on audit corrective actions
- Management review inputs: Performance, compliance, risks
- Management review outputs: Action plans, resource decisions
- Documenting management review meetings
- Auditor expectations for management engagement
Module 14: Preparation for Certification and Surveillance Audits - Selecting a notified body or registrar
- Stage 1 vs Stage 2 audit expectations
- Gathering and organising audit evidence
- Preparing the facility: Documentation, personnel, records
- Conducting mock audits and gap assessments
- Handling auditor questions and requests
- Responding to non-conformities during audits
- Developing audit response and action plans
- Surveillance audit readiness checklist
- Becoming audit-ready: Maintaining a state of continual compliance
Module 15: Leveraging ISO 13485 for Competitive Advantage - Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Positioning QMS as a strategic asset in funding rounds
- Using certification in marketing and RFPs
- Reducing insurance premiums through robust QMS
- Accelerating regulatory submissions with pre-audited systems
- Improving customer trust and reducing liability risk
- Attracting top talent to a quality-driven culture
- Streamlining M&A due diligence with auditable systems
- Driving supplier compliance through QMS integration
- Measuring ROI of QMS investments
- Transforming compliance into innovation enablement
Module 16: Implementation Roadmaps and Project Execution - Gap assessment: Identifying system weaknesses
- Developing a 90-day ISO 13485 implementation plan
- Assigning roles: Project manager, quality lead, sponsor
- Developing a QMS implementation dashboard
- Phased rollout: Pilot areas to full deployment
- Training needs analysis and rollout strategy
- Change management: Overcoming resistance
- Tracking milestones, budget, and resource use
- Communication plan for all stakeholders
- Conducting pre-certification readiness reviews
Module 17: Certification Process and Beyond - Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Submitting application to notified body
- Preparing the quality manual and procedure index
- Final document review and evidence compilation
- Hosting the certification audit
- Responding to audit findings and closing actions
- Receiving certification and maintaining surveillance
- Updating QMS in response to regulatory changes
- Preparing for unannounced audits
- Renewal and re-certification cycles
- Building a culture of continual improvement
Module 18: Advanced Topics and Integration with Other Standards - Integrating ISO 13485 with MDR and IVDR requirements
- Aligning with FDA 21 CFR Part 820
- Mapping to MDSAP audit criteria
- Linking cybersecurity requirements to QMS controls
- Software as a Medical Device (SaMD) considerations
- Integrating Agile development with design controls
- QMS for digital health and AI-driven devices
- Environmental management integration (ISO 14001)
- Information security and data protection (ISO 27001)
- End-to-end compliance integration for global operations
Module 19: Practical Application and Real-World Projects - Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device
Module 20: Certification and Career Advancement - Final assessment and knowledge verification
- Submitting completed project for review
- Feedback and refinement of work products
- Issuance of Certificate of Completion by The Art of Service
- How to list the credential on LinkedIn and CVs
- Leveraging certification in job interviews and promotions
- Joining a network of certified medical device professionals
- Continuing education pathways and advanced courses
- Staying updated: Regulatory alerts and guidance
- Turning mastery into leadership: Next steps for impact
- Case study: Start-up certification in 6 months
- Case study: Migrating from ISO 9001 to ISO 13485
- Case study: Corrective action for major non-conformity
- Template: Risk-based document control system
- Template: Design input validation protocol
- Template: CAPA root cause investigation form
- Template: Internal audit checklist by clause
- Template: Management review agenda and outputs
- Project: Build a QMS implementation roadmap
- Project: Conduct a gap analysis on a sample device