A tailored course, built for your situation
Mastering ISO 13485 & MDR Compliance for MedTech Leaders
A tailored implementation roadmap for senior professionals driving quality and compliance in medical technology
$199 one-time
24-hour access provisioning
30-day money-back guarantee
Hand-built implementation playbook
12 modules. 12 chapters per module. 144 chapters total.
12 modules, each with 12 chapters (144 chapters total), text-based, plus downloadable templates and a hand-built implementation playbook delivered alongside course access.
Staying ahead of evolving MDR requirements while scaling operations is overwhelming without a structured, field-validated approach.
The situation this course is for
Medical technology leaders face increasing pressure to demonstrate compliance while driving innovation. Regulatory audits, shifting interpretations of MDR, and cross-functional alignment create friction in product launches and quality system maintenance. Without a unified framework, teams waste time reconciling standards instead of advancing patient safety and market differentiation.
Who this is for
Senior Operations & Quality Leaders in MedTech and Assistive Technology sectors with responsibility for ISO 13485, MDR compliance, and lean operational transformation.
Who this is not for
Entry-level quality officers, non-medical device manufacturers, or professionals outside regulated technology environments.
What you walk away with
- Build and maintain a living ISO 13485-compliant quality management system
- Navigate MDR documentation and conformity assessment procedures with confidence
- Integrate lean principles into regulatory workflows without compromising compliance
- Lead cross-functional teams through audit readiness and post-market surveillance
- Transform strategic sourcing practices to align with regulatory and quality mandates
The 12 modules (with all 144 chapters)
Module 1. Foundations of ISO 13485 in MedTech
Establish core principles of quality management specific to medical devices, including documentation control, risk-based thinking, and process approach alignment.
12 chapters in this module
- What ISO 13485 means today
- Scope and applicability in MedTech
- Quality manual essentials
- Document hierarchy structure
- Version control best practices
- Risk management linkage
- Process mapping basics
- Internal audit prerequisites
- Management responsibility defined
- Resource allocation framework
- Training plan development
- Performance monitoring setup
Module 2. MDR Regulatory Landscape Overview
Understand the structure and intent of the EU Medical Device Regulation, including scope, classification rules, and conformity pathways.
12 chapters in this module
- MDR vs previous directives
- Scope and exclusions clarified
- Device classification rules
- Conformity assessment routes
- Notified Body engagement
- Technical documentation depth
- UDI system requirements
- Economic operator roles
- Importer and distributor duties
- Vigilance and reporting duties
- Post-market surveillance basics
- Clinical evaluation alignment
Module 3. Quality Management System Design
Design a scalable QMS architecture that integrates seamlessly with existing operations and supports regulatory compliance.
12 chapters in this module
- QMS scope definition
- Process ownership model
- Document control workflow
- Record retention rules
- Change control process
- Deviation management setup
- CAPA system foundation
- Management review inputs
- KPIs for compliance
- Audit scheduling logic
- Supplier control framework
- Continuous improvement loop
Module 4. Design and Development Controls
Implement stage-gated design controls with traceability, verification, and validation protocols aligned to MDR expectations.
12 chapters in this module
- Design control triggers
- Input requirements capture
- Design output specifications
- Design review structure
- Traceability matrix build
- Verification vs validation
- Design transfer process
- Design changes control
- Design history file setup
- Usability engineering link
- Risk analysis integration
- Post-launch monitoring
Module 5. Risk Management Integration
Apply ISO 14971 principles within ISO 13485 and MDR frameworks to ensure patient safety and regulatory alignment.
12 chapters in this module
- Risk management plan
- Hazard identification methods
- Risk analysis techniques
- Risk evaluation criteria
- Risk control measures
- Residual risk assessment
- Benefit-risk analysis
- Production phase risks
- Post-market risk input
- Risk file maintenance
- Usability risk linkage
- Software as medical device
Module 6. Supplier and Sourcing Compliance
Ensure strategic sourcing decisions support quality and regulatory requirements across the supply chain.
12 chapters in this module
- Supplier selection criteria
- Tiered supplier model
- Auditing third parties
- Certificate verification
- Sub-tier oversight
- Dual sourcing strategy
- Component traceability
- Supplier CAPA process
- Incoming inspection rules
- Deviation handling flow
- Contractor oversight
- Performance scorecards
Module 7. Clinical Evaluation and PMCF
Execute clinical evaluation procedures and post-market clinical follow-up plans in line with MDR Article 61.
12 chapters in this module
- Literature search protocol
- Equivalence justification
- Gap analysis method
- Clinical data sources
- Evaluation report structure
- Benefit-risk conclusion
- PMCF plan development
- Data collection tools
- Signal detection process
- Periodic safety update
- Expert panel input
- Notified Body review prep
Module 8. Technical Documentation Preparation
Assemble complete technical documentation dossiers for MDR compliance and audit readiness.
12 chapters in this module
- Device description template
- Intended purpose clarity
- Classification rationale
- Design and manufacturing info
- General Safety checklist
- Essential Requirements mapping
- Risk management summary
- Clinical evaluation summary
- Labeling compliance check
- Instructions for use review
- UDI-DI assignment
- Declaration of conformity
Module 9. Post-Market Surveillance and Vigilance
Develop proactive systems for monitoring device performance and reporting field issues under MDR requirements.
12 chapters in this module
- PMS plan structure
- Data sources integration
- Trend reporting setup
- Field safety notices
- Serious incident reporting
- Field corrective actions
- Trend evaluation process
- Periodic Summary reports
- Complaint handling linkage
- Customer feedback system
- Regulatory update tracking
- Notified Body reporting
Module 10. Audit Readiness and Inspection Flow
Prepare for internal, notified body, and regulatory inspections with confidence and consistency.
12 chapters in this module
- Audit schedule planning
- Internal audit checklist
- Nonconformance handling
- Audit finding classification
- Corrective action workflow
- Management review input
- Inspection readiness check
- Opening meeting protocol
- Documentation access setup
- Interview preparation
- Closing meeting summary
- Follow-up action tracking
Module 11. Lean-Quality Integration
Merge lean operational principles with quality system rigor to eliminate waste without compromising compliance.
12 chapters in this module
- Waste in QMS processes
- Value stream mapping
- Process efficiency gains
- Documentation simplification
- Meeting cadence optimization
- CAPA cycle time reduction
- Audit preparation efficiency
- Training delivery streamlining
- Change control acceleration
- Risk-based prioritization
- Continuous improvement rhythm
- Leadership engagement model
Module 12. Strategic Compliance Leadership
Lead organizational transformation by positioning compliance as a competitive advantage and innovation enabler.
12 chapters in this module
- Compliance vision setting
- Stakeholder alignment
- Regulatory intelligence system
- Change management approach
- Resource advocacy
- Team capability building
- Cross-functional leadership
- Board-level reporting
- Innovation-enabling compliance
- Market differentiation strategy
- Blue ocean linkage
- Future regulation foresight
How this maps to your situation
- New MDR enforcement phase
- Scaling MedTech operations
- Quality system transformation
- Strategic sourcing evolution
Before vs. after
Before
Overwhelmed by fragmented compliance demands and regulatory updates, reacting to audits and delays.
After
Leading with confidence using an integrated quality and regulatory framework that drives efficiency and market advantage.
What's included with your purchase
- 12 modules with 12 chapters each (144 chapters)
- Downloadable templates and worked examples for every module
- Hand-built implementation playbook delivered alongside course access
- 30-day money-back guarantee
Delivery and format
- Course and learning environment access provisioned within 24 hours of purchase
- Hand-built implementation playbook delivered alongside course access
Format: Text-based modules and chapters in the Art of Service learning environment, plus downloadable templates and worked examples for every chapter, plus the hand-built implementation playbook delivered alongside course access.
Time investment: Approximately 3 hours per week over 12 weeks to complete all modules and apply templates.
If nothing changes
Continuing without a unified compliance strategy risks delayed time-to-market, increased audit findings, and missed opportunities to position quality as a strategic lever in competitive MedTech environments.
How this compares to the alternatives
Unlike generic ISO training, this course is tailored to MedTech leaders with real-world templates and MDR-specific guidance. It goes beyond theory with implementation playbooks used in certified environments, unlike academic or video-based alternatives.
Frequently asked
Is this course focused on ISO 13485 or MDR?
It integrates both standards, showing how to align quality management systems with current MDR requirements for medical devices.
How is the course structured?
12 modules, each containing 12 chapters (144 chapters total).
Are the templates customizable?
Yes, all downloadable templates are provided in editable format for immediate adaptation to your organization.
$199 one-time. Approximately 3 hours per week over 12 weeks to complete all modules and apply templates..
Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.
30-day money-back guarantee·
144 chapters·
Hand-built playbook included·
Account access within 24 hours