ISO 13485 Complete Self-Assessment Guide
You're under pressure. Regulatory expectations are tightening. Audits are looming. And every delay in achieving ISO 13485 compliance costs your organisation in credibility, market access, and revenue. You need more than theory. You need a proven, actionable roadmap that turns ISO 13485 from a compliance burden into a strategic asset-fast. The ISO 13485 Complete Self-Assessment Guide is that roadmap. It’s designed for professionals who must move quickly from confusion to clarity, from partial understanding to full readiness, and from reactive firefighting to proactive quality leadership. Imagine delivering a board-ready, audit-proof quality management system in as little as 90 days, with the confidence that every clause is addressed, every gap closed, and every stakeholder aligned. That’s exactly what Elena R., a Senior Quality Assurance Manager at a Class II medical device manufacturer in Germany, achieved. After using this guide, her team passed their first notified body audit with zero major non-conformities-and reduced internal audit preparation time by 70%. This isn’t just another checklist. It’s the systematic, expert-vetted framework trusted by over 4,200 medical device professionals to streamline compliance, strengthen risk management, and accelerate time to market. Here’s how this course is structured to help you get there.Course Format & Delivery Details The ISO 13485 Complete Self-Assessment Guide is a fully self-paced, on-demand program with immediate online access. You begin the moment your role demands it-with no fixed start dates, no time zone restrictions, and no waiting. Flexible & Immediate Access
You control the pace. Most learners complete the core assessment framework in 60–90 hours, with many applying critical components within the first 10 hours. This means you can start building compliant processes, conducting internal reviews, and documenting improvements from Day One. - Lifetime access to all course materials
- Ongoing future updates included at no additional cost
- 24/7 global access from any device, including smartphones and tablets
- Mobile-friendly design ensures seamless progress, whether you’re in the office, at a supplier site, or preparing for an audit
Expert Guidance & Support
You’re not alone. Every enrolment includes direct access to our expert QMS advisors for clarification, context, and implementation guidance. Submit your questions through the secure portal and receive detailed written feedback within 48 business hours. Our support is specifically designed for real-world application-helping you interpret complex clauses, tailor documentation to your device class, and resolve implementation dilemmas with confidence. Certificate of Completion – Globally Recognised
Upon successful completion, you will receive a Certificate of Completion issued by The Art of Service-a globally respected authority in professional certification for quality, compliance, and regulatory standards. This certificate is recognised by auditors, hiring managers, and notified bodies across the EU, North America, and Asia. It demonstrates your commitment to excellence, deep understanding of ISO 13485, and ability to lead or support a compliant QMS implementation. Transparent Pricing, Zero Risk
You will never encounter hidden fees. The price you see is the price you pay-complete, final, and inclusive of all materials, support, and certification. We accept all major payment methods: Visa, Mastercard, and PayPal. Transactions are processed securely with end-to-end encryption, ensuring your data remains protected. Satisfied or Refunded – 30-Day Guarantee
If you’re not confident that this guide will transform your approach to ISO 13485 compliance within 30 days of enrollment, simply request a full refund. No questions asked. No hassle. This is our promise: you take zero financial risk, but stand to gain significant competitive and career advantage. What Happens After Enrollment?
Once you enrol, you’ll receive a confirmation email. Shortly after, a second email will deliver your secure access credentials and instructions for entering the learning environment-ensuring a smooth, professional onboarding experience. Will This Work for Me?
Yes-regardless of your organisation’s size, device classification, or stage in the compliance journey. This guide works even if you’re transitioning from ISO 9001, managing a startup’s first QMS, supporting a notified body audit, or leading a compliance overhaul in a multinational team. It’s been used successfully by Quality Managers, Regulatory Affairs Specialists, R&D Leads, and Senior Executives across 68 countries-with documented success in achieving compliance for Class I, IIa, IIb, and III devices. This is not just a guide. It’s your proven path to certification readiness, audit confidence, and career advancement-backed by a global standard of excellence.
Module 1: Foundations of ISO 13485 and Regulatory Context - Understanding the purpose and scope of ISO 13485
- How ISO 13485 differs from ISO 9001
- Mapping ISO 13485 to MDR and IVDR requirements
- Applicability across medical device classifications
- Key definitions and terminology used throughout the standard
- Regulatory expectations in the EU, US, Canada, and Asia-Pacific
- The role of notified bodies and regulatory authorities
- Hierarchy of regulatory documents and quality system integration
- Risk-based approach as the foundation of compliance
- Establishing your organisation’s regulatory footprint
Module 2: Leadership and Management Responsibility - Defining top management’s role in compliance
- Assigning quality policy ownership and accountability
- Developing a clear, enforceable quality policy
- Setting measurable quality objectives
- Resource planning and allocation for QMS success
- Ensuring management review effectiveness
- Documenting review frequency, inputs, and outputs
- Integrating compliance into business strategy
- Creating a culture of quality and continuous improvement
- Aligning leadership actions with regulatory expectations
Module 3: Planning for Quality Management - Identifying internal and external factors affecting QMS
- Conducting a thorough context analysis
- Stakeholder identification and expectation mapping
- Risk and opportunity assessment in planning phase
- Defining quality planning objectives
- Establishing measurable success criteria
- Change management planning within QMS
- Integration of planning across departments
- Documenting planning decisions and rationale
- Linking planning to product lifecycle stages
Module 4: Support Functions and Resource Management - Identifying necessary resources for QMS implementation
- Personnel competency and training requirements
- Developing job-specific training plans
- Documenting training records and evaluations
- Infrastructure and work environment controls
- Purchase of external services and their oversight
- Control of monitoring and measuring equipment
- Calibration schedules and traceability
- Managing outsourced processes and suppliers
- Ensuring availability of documented information
Module 5: Document Control and Record Management - Types of documented information required by ISO 13485
- Creating a document hierarchy and numbering system
- Document approval, review, and revision processes
- Version control and change tracking
- Secure storage and retrieval of records
- Retention periods for different record types
- Electronic document management best practices
- Ensuring document availability at point of use
- Control of external documents and standards
- Preventing unauthorised document access or changes
Module 6: Design and Development of Medical Devices - Setting design and development planning requirements
- Establishing design inputs with traceability
- Design review processes and participation criteria
- Verification vs validation: key differences and application
- Design output documentation and specifications
- Design transfer to manufacturing
- Design changes and change control procedures
- Design history file (DHF) structure and content
- User interface and usability engineering integration
- Software validation within design controls
Module 7: Purchasing and Supplier Management - Establishing supplier selection and evaluation criteria
- Managing supplier audits and performance reviews
- Control of purchased product and services
- Supplier qualification and requalification processes
- Purchase order controls and specification alignment
- Managing critical vs non-critical suppliers
- Supplier nonconformance handling
- Subcontractor oversight and regulatory flowdown
- Monitoring supplier quality data
- Ensuring supplier compliance with ISO 13485
Module 8: Production and Process Controls - Production planning and control documentation
- Work instructions and operator training
- Process validation requirements
- Installation and servicing controls
- Special processes and qualification needs
- Control of contamination and cleanroom environments
- Labelling and packaging controls
- Traceability requirements for UDI compliance
- Preventive maintenance systems
- Handling nonconforming product during production
Module 9: Risk Management According to ISO 14971 - Integrating ISO 14971 with ISO 13485
- Risk management file (RMF) structure and maintenance
- Conducting hazard identification
- Performing risk analysis and evaluation
- Implementing risk control measures
- Risk-benefit analysis for mitigation decisions
- Verification of risk control implementation
- Production and post-production information collection
- Risk management during design transfer
- Updating the RMF throughout product lifecycle
Module 10: Measurement, Analysis, and Improvement - Monitoring processes for effectiveness
- Customer feedback collection and analysis
- Auditing internal processes and compliance
- Implementing corrective and preventive actions (CAPA)
- Tracking process performance indicators
- Analysing data for decision making
- Internal audit scheduling and planning
- Selecting qualified internal auditors
- Reporting audit findings and closing nonconformities
- Using data to drive continuous improvement
Module 11: Internal Audit and Compliance Verification - Developing an internal audit programme
- Creating audit checklists for each clause
- Conducting audit opening and closing meetings
- Interviewing personnel during audits
- Identifying objective evidence
- Distinguishing between minor and major nonconformities
- Writing clear, actionable audit reports
- Tracking audit findings to closure
- Using audit results for management review
- Preparing for external audits via internal simulations
Module 12: Corrective and Preventive Action (CAPA) - Establishing CAPA triggers and initiation criteria
- Root cause analysis techniques (5 Whys, Fishbone, etc.)
- Documenting investigation findings
- Implementing and verifying corrective actions
- Assessing effectiveness of corrective measures
- Preventing recurrence through systemic fixes
- Distinguishing CAPA from routine corrections
- CAPA trending and analysis
- Closing CAPA records with full traceability
- Integrating CAPA with risk management and design
Module 13: Regulatory and Notified Body Audits - Preparing for initial certification audits
- Understanding audit stages and timelines
- Compiling the audit dossier
- Conducting readiness assessments
- Simulating mock audits
- Responding to audit findings and nonconformities
- Managing surveillance and recertification audits
- Handling major and critical findings
- Negotiating with auditors professionally
- Implementing post-audit action plans
Module 14: Post-Market Surveillance and Vigilance - Linking PMS to ISO 13485 and MDR
- Establishing PMS planning and procedures
- Collecting and analysing field data
- Managing customer complaints effectively
- Determining reportable events
- Submitting field safety corrective actions (FSCA)
- Integrating PMS into risk management
- Conducting periodic safety update reports (PSUR)
- Monitoring social media and online feedback
- Using post-market data for product improvement
Module 15: Change Management and Continual Improvement - Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Understanding the purpose and scope of ISO 13485
- How ISO 13485 differs from ISO 9001
- Mapping ISO 13485 to MDR and IVDR requirements
- Applicability across medical device classifications
- Key definitions and terminology used throughout the standard
- Regulatory expectations in the EU, US, Canada, and Asia-Pacific
- The role of notified bodies and regulatory authorities
- Hierarchy of regulatory documents and quality system integration
- Risk-based approach as the foundation of compliance
- Establishing your organisation’s regulatory footprint
Module 2: Leadership and Management Responsibility - Defining top management’s role in compliance
- Assigning quality policy ownership and accountability
- Developing a clear, enforceable quality policy
- Setting measurable quality objectives
- Resource planning and allocation for QMS success
- Ensuring management review effectiveness
- Documenting review frequency, inputs, and outputs
- Integrating compliance into business strategy
- Creating a culture of quality and continuous improvement
- Aligning leadership actions with regulatory expectations
Module 3: Planning for Quality Management - Identifying internal and external factors affecting QMS
- Conducting a thorough context analysis
- Stakeholder identification and expectation mapping
- Risk and opportunity assessment in planning phase
- Defining quality planning objectives
- Establishing measurable success criteria
- Change management planning within QMS
- Integration of planning across departments
- Documenting planning decisions and rationale
- Linking planning to product lifecycle stages
Module 4: Support Functions and Resource Management - Identifying necessary resources for QMS implementation
- Personnel competency and training requirements
- Developing job-specific training plans
- Documenting training records and evaluations
- Infrastructure and work environment controls
- Purchase of external services and their oversight
- Control of monitoring and measuring equipment
- Calibration schedules and traceability
- Managing outsourced processes and suppliers
- Ensuring availability of documented information
Module 5: Document Control and Record Management - Types of documented information required by ISO 13485
- Creating a document hierarchy and numbering system
- Document approval, review, and revision processes
- Version control and change tracking
- Secure storage and retrieval of records
- Retention periods for different record types
- Electronic document management best practices
- Ensuring document availability at point of use
- Control of external documents and standards
- Preventing unauthorised document access or changes
Module 6: Design and Development of Medical Devices - Setting design and development planning requirements
- Establishing design inputs with traceability
- Design review processes and participation criteria
- Verification vs validation: key differences and application
- Design output documentation and specifications
- Design transfer to manufacturing
- Design changes and change control procedures
- Design history file (DHF) structure and content
- User interface and usability engineering integration
- Software validation within design controls
Module 7: Purchasing and Supplier Management - Establishing supplier selection and evaluation criteria
- Managing supplier audits and performance reviews
- Control of purchased product and services
- Supplier qualification and requalification processes
- Purchase order controls and specification alignment
- Managing critical vs non-critical suppliers
- Supplier nonconformance handling
- Subcontractor oversight and regulatory flowdown
- Monitoring supplier quality data
- Ensuring supplier compliance with ISO 13485
Module 8: Production and Process Controls - Production planning and control documentation
- Work instructions and operator training
- Process validation requirements
- Installation and servicing controls
- Special processes and qualification needs
- Control of contamination and cleanroom environments
- Labelling and packaging controls
- Traceability requirements for UDI compliance
- Preventive maintenance systems
- Handling nonconforming product during production
Module 9: Risk Management According to ISO 14971 - Integrating ISO 14971 with ISO 13485
- Risk management file (RMF) structure and maintenance
- Conducting hazard identification
- Performing risk analysis and evaluation
- Implementing risk control measures
- Risk-benefit analysis for mitigation decisions
- Verification of risk control implementation
- Production and post-production information collection
- Risk management during design transfer
- Updating the RMF throughout product lifecycle
Module 10: Measurement, Analysis, and Improvement - Monitoring processes for effectiveness
- Customer feedback collection and analysis
- Auditing internal processes and compliance
- Implementing corrective and preventive actions (CAPA)
- Tracking process performance indicators
- Analysing data for decision making
- Internal audit scheduling and planning
- Selecting qualified internal auditors
- Reporting audit findings and closing nonconformities
- Using data to drive continuous improvement
Module 11: Internal Audit and Compliance Verification - Developing an internal audit programme
- Creating audit checklists for each clause
- Conducting audit opening and closing meetings
- Interviewing personnel during audits
- Identifying objective evidence
- Distinguishing between minor and major nonconformities
- Writing clear, actionable audit reports
- Tracking audit findings to closure
- Using audit results for management review
- Preparing for external audits via internal simulations
Module 12: Corrective and Preventive Action (CAPA) - Establishing CAPA triggers and initiation criteria
- Root cause analysis techniques (5 Whys, Fishbone, etc.)
- Documenting investigation findings
- Implementing and verifying corrective actions
- Assessing effectiveness of corrective measures
- Preventing recurrence through systemic fixes
- Distinguishing CAPA from routine corrections
- CAPA trending and analysis
- Closing CAPA records with full traceability
- Integrating CAPA with risk management and design
Module 13: Regulatory and Notified Body Audits - Preparing for initial certification audits
- Understanding audit stages and timelines
- Compiling the audit dossier
- Conducting readiness assessments
- Simulating mock audits
- Responding to audit findings and nonconformities
- Managing surveillance and recertification audits
- Handling major and critical findings
- Negotiating with auditors professionally
- Implementing post-audit action plans
Module 14: Post-Market Surveillance and Vigilance - Linking PMS to ISO 13485 and MDR
- Establishing PMS planning and procedures
- Collecting and analysing field data
- Managing customer complaints effectively
- Determining reportable events
- Submitting field safety corrective actions (FSCA)
- Integrating PMS into risk management
- Conducting periodic safety update reports (PSUR)
- Monitoring social media and online feedback
- Using post-market data for product improvement
Module 15: Change Management and Continual Improvement - Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Identifying internal and external factors affecting QMS
- Conducting a thorough context analysis
- Stakeholder identification and expectation mapping
- Risk and opportunity assessment in planning phase
- Defining quality planning objectives
- Establishing measurable success criteria
- Change management planning within QMS
- Integration of planning across departments
- Documenting planning decisions and rationale
- Linking planning to product lifecycle stages
Module 4: Support Functions and Resource Management - Identifying necessary resources for QMS implementation
- Personnel competency and training requirements
- Developing job-specific training plans
- Documenting training records and evaluations
- Infrastructure and work environment controls
- Purchase of external services and their oversight
- Control of monitoring and measuring equipment
- Calibration schedules and traceability
- Managing outsourced processes and suppliers
- Ensuring availability of documented information
Module 5: Document Control and Record Management - Types of documented information required by ISO 13485
- Creating a document hierarchy and numbering system
- Document approval, review, and revision processes
- Version control and change tracking
- Secure storage and retrieval of records
- Retention periods for different record types
- Electronic document management best practices
- Ensuring document availability at point of use
- Control of external documents and standards
- Preventing unauthorised document access or changes
Module 6: Design and Development of Medical Devices - Setting design and development planning requirements
- Establishing design inputs with traceability
- Design review processes and participation criteria
- Verification vs validation: key differences and application
- Design output documentation and specifications
- Design transfer to manufacturing
- Design changes and change control procedures
- Design history file (DHF) structure and content
- User interface and usability engineering integration
- Software validation within design controls
Module 7: Purchasing and Supplier Management - Establishing supplier selection and evaluation criteria
- Managing supplier audits and performance reviews
- Control of purchased product and services
- Supplier qualification and requalification processes
- Purchase order controls and specification alignment
- Managing critical vs non-critical suppliers
- Supplier nonconformance handling
- Subcontractor oversight and regulatory flowdown
- Monitoring supplier quality data
- Ensuring supplier compliance with ISO 13485
Module 8: Production and Process Controls - Production planning and control documentation
- Work instructions and operator training
- Process validation requirements
- Installation and servicing controls
- Special processes and qualification needs
- Control of contamination and cleanroom environments
- Labelling and packaging controls
- Traceability requirements for UDI compliance
- Preventive maintenance systems
- Handling nonconforming product during production
Module 9: Risk Management According to ISO 14971 - Integrating ISO 14971 with ISO 13485
- Risk management file (RMF) structure and maintenance
- Conducting hazard identification
- Performing risk analysis and evaluation
- Implementing risk control measures
- Risk-benefit analysis for mitigation decisions
- Verification of risk control implementation
- Production and post-production information collection
- Risk management during design transfer
- Updating the RMF throughout product lifecycle
Module 10: Measurement, Analysis, and Improvement - Monitoring processes for effectiveness
- Customer feedback collection and analysis
- Auditing internal processes and compliance
- Implementing corrective and preventive actions (CAPA)
- Tracking process performance indicators
- Analysing data for decision making
- Internal audit scheduling and planning
- Selecting qualified internal auditors
- Reporting audit findings and closing nonconformities
- Using data to drive continuous improvement
Module 11: Internal Audit and Compliance Verification - Developing an internal audit programme
- Creating audit checklists for each clause
- Conducting audit opening and closing meetings
- Interviewing personnel during audits
- Identifying objective evidence
- Distinguishing between minor and major nonconformities
- Writing clear, actionable audit reports
- Tracking audit findings to closure
- Using audit results for management review
- Preparing for external audits via internal simulations
Module 12: Corrective and Preventive Action (CAPA) - Establishing CAPA triggers and initiation criteria
- Root cause analysis techniques (5 Whys, Fishbone, etc.)
- Documenting investigation findings
- Implementing and verifying corrective actions
- Assessing effectiveness of corrective measures
- Preventing recurrence through systemic fixes
- Distinguishing CAPA from routine corrections
- CAPA trending and analysis
- Closing CAPA records with full traceability
- Integrating CAPA with risk management and design
Module 13: Regulatory and Notified Body Audits - Preparing for initial certification audits
- Understanding audit stages and timelines
- Compiling the audit dossier
- Conducting readiness assessments
- Simulating mock audits
- Responding to audit findings and nonconformities
- Managing surveillance and recertification audits
- Handling major and critical findings
- Negotiating with auditors professionally
- Implementing post-audit action plans
Module 14: Post-Market Surveillance and Vigilance - Linking PMS to ISO 13485 and MDR
- Establishing PMS planning and procedures
- Collecting and analysing field data
- Managing customer complaints effectively
- Determining reportable events
- Submitting field safety corrective actions (FSCA)
- Integrating PMS into risk management
- Conducting periodic safety update reports (PSUR)
- Monitoring social media and online feedback
- Using post-market data for product improvement
Module 15: Change Management and Continual Improvement - Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Types of documented information required by ISO 13485
- Creating a document hierarchy and numbering system
- Document approval, review, and revision processes
- Version control and change tracking
- Secure storage and retrieval of records
- Retention periods for different record types
- Electronic document management best practices
- Ensuring document availability at point of use
- Control of external documents and standards
- Preventing unauthorised document access or changes
Module 6: Design and Development of Medical Devices - Setting design and development planning requirements
- Establishing design inputs with traceability
- Design review processes and participation criteria
- Verification vs validation: key differences and application
- Design output documentation and specifications
- Design transfer to manufacturing
- Design changes and change control procedures
- Design history file (DHF) structure and content
- User interface and usability engineering integration
- Software validation within design controls
Module 7: Purchasing and Supplier Management - Establishing supplier selection and evaluation criteria
- Managing supplier audits and performance reviews
- Control of purchased product and services
- Supplier qualification and requalification processes
- Purchase order controls and specification alignment
- Managing critical vs non-critical suppliers
- Supplier nonconformance handling
- Subcontractor oversight and regulatory flowdown
- Monitoring supplier quality data
- Ensuring supplier compliance with ISO 13485
Module 8: Production and Process Controls - Production planning and control documentation
- Work instructions and operator training
- Process validation requirements
- Installation and servicing controls
- Special processes and qualification needs
- Control of contamination and cleanroom environments
- Labelling and packaging controls
- Traceability requirements for UDI compliance
- Preventive maintenance systems
- Handling nonconforming product during production
Module 9: Risk Management According to ISO 14971 - Integrating ISO 14971 with ISO 13485
- Risk management file (RMF) structure and maintenance
- Conducting hazard identification
- Performing risk analysis and evaluation
- Implementing risk control measures
- Risk-benefit analysis for mitigation decisions
- Verification of risk control implementation
- Production and post-production information collection
- Risk management during design transfer
- Updating the RMF throughout product lifecycle
Module 10: Measurement, Analysis, and Improvement - Monitoring processes for effectiveness
- Customer feedback collection and analysis
- Auditing internal processes and compliance
- Implementing corrective and preventive actions (CAPA)
- Tracking process performance indicators
- Analysing data for decision making
- Internal audit scheduling and planning
- Selecting qualified internal auditors
- Reporting audit findings and closing nonconformities
- Using data to drive continuous improvement
Module 11: Internal Audit and Compliance Verification - Developing an internal audit programme
- Creating audit checklists for each clause
- Conducting audit opening and closing meetings
- Interviewing personnel during audits
- Identifying objective evidence
- Distinguishing between minor and major nonconformities
- Writing clear, actionable audit reports
- Tracking audit findings to closure
- Using audit results for management review
- Preparing for external audits via internal simulations
Module 12: Corrective and Preventive Action (CAPA) - Establishing CAPA triggers and initiation criteria
- Root cause analysis techniques (5 Whys, Fishbone, etc.)
- Documenting investigation findings
- Implementing and verifying corrective actions
- Assessing effectiveness of corrective measures
- Preventing recurrence through systemic fixes
- Distinguishing CAPA from routine corrections
- CAPA trending and analysis
- Closing CAPA records with full traceability
- Integrating CAPA with risk management and design
Module 13: Regulatory and Notified Body Audits - Preparing for initial certification audits
- Understanding audit stages and timelines
- Compiling the audit dossier
- Conducting readiness assessments
- Simulating mock audits
- Responding to audit findings and nonconformities
- Managing surveillance and recertification audits
- Handling major and critical findings
- Negotiating with auditors professionally
- Implementing post-audit action plans
Module 14: Post-Market Surveillance and Vigilance - Linking PMS to ISO 13485 and MDR
- Establishing PMS planning and procedures
- Collecting and analysing field data
- Managing customer complaints effectively
- Determining reportable events
- Submitting field safety corrective actions (FSCA)
- Integrating PMS into risk management
- Conducting periodic safety update reports (PSUR)
- Monitoring social media and online feedback
- Using post-market data for product improvement
Module 15: Change Management and Continual Improvement - Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Establishing supplier selection and evaluation criteria
- Managing supplier audits and performance reviews
- Control of purchased product and services
- Supplier qualification and requalification processes
- Purchase order controls and specification alignment
- Managing critical vs non-critical suppliers
- Supplier nonconformance handling
- Subcontractor oversight and regulatory flowdown
- Monitoring supplier quality data
- Ensuring supplier compliance with ISO 13485
Module 8: Production and Process Controls - Production planning and control documentation
- Work instructions and operator training
- Process validation requirements
- Installation and servicing controls
- Special processes and qualification needs
- Control of contamination and cleanroom environments
- Labelling and packaging controls
- Traceability requirements for UDI compliance
- Preventive maintenance systems
- Handling nonconforming product during production
Module 9: Risk Management According to ISO 14971 - Integrating ISO 14971 with ISO 13485
- Risk management file (RMF) structure and maintenance
- Conducting hazard identification
- Performing risk analysis and evaluation
- Implementing risk control measures
- Risk-benefit analysis for mitigation decisions
- Verification of risk control implementation
- Production and post-production information collection
- Risk management during design transfer
- Updating the RMF throughout product lifecycle
Module 10: Measurement, Analysis, and Improvement - Monitoring processes for effectiveness
- Customer feedback collection and analysis
- Auditing internal processes and compliance
- Implementing corrective and preventive actions (CAPA)
- Tracking process performance indicators
- Analysing data for decision making
- Internal audit scheduling and planning
- Selecting qualified internal auditors
- Reporting audit findings and closing nonconformities
- Using data to drive continuous improvement
Module 11: Internal Audit and Compliance Verification - Developing an internal audit programme
- Creating audit checklists for each clause
- Conducting audit opening and closing meetings
- Interviewing personnel during audits
- Identifying objective evidence
- Distinguishing between minor and major nonconformities
- Writing clear, actionable audit reports
- Tracking audit findings to closure
- Using audit results for management review
- Preparing for external audits via internal simulations
Module 12: Corrective and Preventive Action (CAPA) - Establishing CAPA triggers and initiation criteria
- Root cause analysis techniques (5 Whys, Fishbone, etc.)
- Documenting investigation findings
- Implementing and verifying corrective actions
- Assessing effectiveness of corrective measures
- Preventing recurrence through systemic fixes
- Distinguishing CAPA from routine corrections
- CAPA trending and analysis
- Closing CAPA records with full traceability
- Integrating CAPA with risk management and design
Module 13: Regulatory and Notified Body Audits - Preparing for initial certification audits
- Understanding audit stages and timelines
- Compiling the audit dossier
- Conducting readiness assessments
- Simulating mock audits
- Responding to audit findings and nonconformities
- Managing surveillance and recertification audits
- Handling major and critical findings
- Negotiating with auditors professionally
- Implementing post-audit action plans
Module 14: Post-Market Surveillance and Vigilance - Linking PMS to ISO 13485 and MDR
- Establishing PMS planning and procedures
- Collecting and analysing field data
- Managing customer complaints effectively
- Determining reportable events
- Submitting field safety corrective actions (FSCA)
- Integrating PMS into risk management
- Conducting periodic safety update reports (PSUR)
- Monitoring social media and online feedback
- Using post-market data for product improvement
Module 15: Change Management and Continual Improvement - Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Integrating ISO 14971 with ISO 13485
- Risk management file (RMF) structure and maintenance
- Conducting hazard identification
- Performing risk analysis and evaluation
- Implementing risk control measures
- Risk-benefit analysis for mitigation decisions
- Verification of risk control implementation
- Production and post-production information collection
- Risk management during design transfer
- Updating the RMF throughout product lifecycle
Module 10: Measurement, Analysis, and Improvement - Monitoring processes for effectiveness
- Customer feedback collection and analysis
- Auditing internal processes and compliance
- Implementing corrective and preventive actions (CAPA)
- Tracking process performance indicators
- Analysing data for decision making
- Internal audit scheduling and planning
- Selecting qualified internal auditors
- Reporting audit findings and closing nonconformities
- Using data to drive continuous improvement
Module 11: Internal Audit and Compliance Verification - Developing an internal audit programme
- Creating audit checklists for each clause
- Conducting audit opening and closing meetings
- Interviewing personnel during audits
- Identifying objective evidence
- Distinguishing between minor and major nonconformities
- Writing clear, actionable audit reports
- Tracking audit findings to closure
- Using audit results for management review
- Preparing for external audits via internal simulations
Module 12: Corrective and Preventive Action (CAPA) - Establishing CAPA triggers and initiation criteria
- Root cause analysis techniques (5 Whys, Fishbone, etc.)
- Documenting investigation findings
- Implementing and verifying corrective actions
- Assessing effectiveness of corrective measures
- Preventing recurrence through systemic fixes
- Distinguishing CAPA from routine corrections
- CAPA trending and analysis
- Closing CAPA records with full traceability
- Integrating CAPA with risk management and design
Module 13: Regulatory and Notified Body Audits - Preparing for initial certification audits
- Understanding audit stages and timelines
- Compiling the audit dossier
- Conducting readiness assessments
- Simulating mock audits
- Responding to audit findings and nonconformities
- Managing surveillance and recertification audits
- Handling major and critical findings
- Negotiating with auditors professionally
- Implementing post-audit action plans
Module 14: Post-Market Surveillance and Vigilance - Linking PMS to ISO 13485 and MDR
- Establishing PMS planning and procedures
- Collecting and analysing field data
- Managing customer complaints effectively
- Determining reportable events
- Submitting field safety corrective actions (FSCA)
- Integrating PMS into risk management
- Conducting periodic safety update reports (PSUR)
- Monitoring social media and online feedback
- Using post-market data for product improvement
Module 15: Change Management and Continual Improvement - Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Developing an internal audit programme
- Creating audit checklists for each clause
- Conducting audit opening and closing meetings
- Interviewing personnel during audits
- Identifying objective evidence
- Distinguishing between minor and major nonconformities
- Writing clear, actionable audit reports
- Tracking audit findings to closure
- Using audit results for management review
- Preparing for external audits via internal simulations
Module 12: Corrective and Preventive Action (CAPA) - Establishing CAPA triggers and initiation criteria
- Root cause analysis techniques (5 Whys, Fishbone, etc.)
- Documenting investigation findings
- Implementing and verifying corrective actions
- Assessing effectiveness of corrective measures
- Preventing recurrence through systemic fixes
- Distinguishing CAPA from routine corrections
- CAPA trending and analysis
- Closing CAPA records with full traceability
- Integrating CAPA with risk management and design
Module 13: Regulatory and Notified Body Audits - Preparing for initial certification audits
- Understanding audit stages and timelines
- Compiling the audit dossier
- Conducting readiness assessments
- Simulating mock audits
- Responding to audit findings and nonconformities
- Managing surveillance and recertification audits
- Handling major and critical findings
- Negotiating with auditors professionally
- Implementing post-audit action plans
Module 14: Post-Market Surveillance and Vigilance - Linking PMS to ISO 13485 and MDR
- Establishing PMS planning and procedures
- Collecting and analysing field data
- Managing customer complaints effectively
- Determining reportable events
- Submitting field safety corrective actions (FSCA)
- Integrating PMS into risk management
- Conducting periodic safety update reports (PSUR)
- Monitoring social media and online feedback
- Using post-market data for product improvement
Module 15: Change Management and Continual Improvement - Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Preparing for initial certification audits
- Understanding audit stages and timelines
- Compiling the audit dossier
- Conducting readiness assessments
- Simulating mock audits
- Responding to audit findings and nonconformities
- Managing surveillance and recertification audits
- Handling major and critical findings
- Negotiating with auditors professionally
- Implementing post-audit action plans
Module 14: Post-Market Surveillance and Vigilance - Linking PMS to ISO 13485 and MDR
- Establishing PMS planning and procedures
- Collecting and analysing field data
- Managing customer complaints effectively
- Determining reportable events
- Submitting field safety corrective actions (FSCA)
- Integrating PMS into risk management
- Conducting periodic safety update reports (PSUR)
- Monitoring social media and online feedback
- Using post-market data for product improvement
Module 15: Change Management and Continual Improvement - Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Establishing formal change control procedures
- Assessing impact of changes on QMS and product
- Documenting change requests and approvals
- Validation of changes in design, process, or supplier
- Communication of changes across departments
- Trending change frequency and types
- Using data to prioritise improvement initiatives
- Implementing kaizen and lean methodologies
- Measuring improvement effectiveness
- Institutionalising continual improvement culture
Module 16: Integration with Other Quality and Regulatory Standards - Aligning ISO 13485 with FDA QSR (21 CFR Part 820)
- Mapping to Health Canada requirements
- Harmonising with global regulatory expectations
- Integrating GMP for sterile devices
- Aligning with IEC 60601 for electrical safety
- Connecting to Usability Engineering (IEC 62366)
- Linking software lifecycle standards (IEC 62304)
- Ensuring UDI compliance and data submission
- Integrating cybersecurity risk management
- Preparing for international market submissions
Module 17: Self-Assessment Tools and Implementation Frameworks - Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Using the ISO 13485 self-assessment matrix
- Gap analysis templates for each clause
- Compliance scoring and maturity assessment
- Setting realistic implementation timelines
- Project management tools for QMS rollout
- Resource allocation planning worksheets
- Departmental responsibility mapping
- Stakeholder communication plans
- Progress tracking dashboards
- Implementation risk assessment and mitigation
Module 18: Real-World Implementation Projects - Conducting a mock QMS implementation for a Class II device
- Building a quality manual from scratch
- Writing SOPs for design controls and risk management
- Developing an internal audit schedule
- Creating a CAPA log with sample entries
- Drafting management review meeting minutes
- Completing a full clause-by-clause checklist
- Preparing a regulatory audit response document
- Simulating a design review meeting
- Compiling a DHF and RMF portfolio
Module 19: Certification Process and Next Steps - Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites
Module 20: Career Advancement and Professional Credibility - How ISO 13485 expertise enhances your CV
- Leveraging your Certificate of Completion
- Positioning yourself as a compliance leader
- Bridging into Regulatory Affairs or QA Management
- Using the guide for team training and leadership
- Networking with global professionals
- Sharing achievements with professional bodies
- Certification recognition by employers
- Advancing to Lead Auditor or Consultant roles
- Contributing to regulatory strategy at executive level
- Selecting an accredited certification body
- Understanding certification scope definition
- Submitting application and obtaining quote
- Preparing for Stage 1 documentation review
- Conducting a readiness audit
- Hosting the Stage 2 certification audit
- Responding to certification findings
- Maintaining certification through surveillance
- Preparing for recertification audits
- Expanding scope to new products or sites