Many medical device teams struggle with:
• Understanding how to implement ISO 14971 requirements in practice
• Maintaining a compliant Risk Management File
• Knowing when risk management activities must occur during development
• Aligning risk processes with design controls and quality systems
• Preparing documentation that stands up to EU MDR and regulatory audits
Participants learn a structured, practical approach to risk management, including:
• Step-by-step implementation guidance
• Documentation strategies that pass audits
• Templates and checklists used by industry professionals
• Integration of risk management into development workflows
By the end of the course, participants will be able to apply ISO-aligned risk management throughout the entire product lifecycle.
Many medical device teams struggle with:
• Understanding how to implement ISO 14971 requirements in practice
• Maintaining a compliant Risk Management File
• Knowing when risk management activities must occur during development
• Aligning risk processes with design controls and quality systems
• Preparing documentation that stands up to EU MDR and regulatory audits
Participants learn a structured, practical approach to risk management, including:
• Step-by-step implementation guidance
• Documentation strategies that pass audits
• Templates and checklists used by industry professionals
• Integration of risk management into development workflows
By the end of the course, participants will be able to apply ISO-aligned risk management throughout the entire product lifecycle.
Core concepts and terminology of medical device risk management
Understanding ISO 14971:2019 principles and structure
The role of risk management in compliant device development
Step-by-step risk management workflow
Risk identification, analysis, evaluation, and control
Practical methods for documenting and justifying risk decisions
How to build and maintain a compliant Risk Management File
Documentation expectations for audits and regulatory submissions
Templates and practical tools used in real device companies
Integrating risk management into the product lifecycle
Alignment with design controls and quality systems
EU MDR expectations related to medical device risk management
Core concepts and terminology of medical device risk management
Understanding ISO 14971:2019 principles and structure
The role of risk management in compliant device development
Step-by-step risk management workflow
Risk identification, analysis, evaluation, and control
Practical methods for documenting and justifying risk decisions
How to build and maintain a compliant Risk Management File
Documentation expectations for audits and regulatory submissions
Templates and practical tools used in real device companies
Integrating risk management into the product lifecycle
Alignment with design controls and quality systems
EU MDR expectations related to medical device risk management
Integrate risk management into product design and development processes.
Build compliant risk management systems and prepare for audits.
Understand how risk management supports successful regulatory submissions.
Apply structured risk analysis to improve product safety and performance.
Integrate risk management into product design and development processes.
Build compliant risk management systems and prepare for audits.
Understand how risk management supports successful regulatory submissions.
Apply structured risk analysis to improve product safety and performance.
Senior consultant in medical device quality and global regulatory compliance. Expert in ISO 13485, EU MDR/IVDR, FDA QSR, and sterilization validation.
Areas of expertise: • Medical Device Quality Systems • Global Regulatory Compliance • ISO 13485 & MDR/IVDR • FDA & MDSAP Readiness • Sterilization Validation and Auditing
20+ years regulatory & quality consulting in medical devices
Expert in ISO 13485, EU MDR/IVDR, FDA QSR & global submissions
Senior consultant at R&Q with extensive FDA, EU & Health Canada experience
Former Sanofi-Aventis Regulatory Affairs Manager & international marketing leader
Senior consultant in medical device quality and global regulatory compliance. Expert in ISO 13485, EU MDR/IVDR, FDA QSR, and sterilization validation.
Areas of expertise: • Medical Device Quality Systems • Global Regulatory Compliance • ISO 13485 & MDR/IVDR • FDA & MDSAP Readiness • Sterilization Validation and Auditing
20+ years regulatory & quality consulting in medical devices
Expert in ISO 13485, EU MDR/IVDR, FDA QSR & global submissions
Senior consultant at R&Q with extensive FDA, EU & Health Canada experience
Former Sanofi-Aventis Regulatory Affairs Manager & international marketing leader
Interactive sessions with real-time Q&A and expert guidance
Two intensive sessions: 10:00-13:30 EST each day
Comprehensive coverage in convenient half-day sessions
Review sessions and reference materials at your own pace
No. The course is suitable for both beginners and experienced professionals.
Yes. Participants receive templates and checklists that support real implementation.
Yes. The course fully reflects ISO 14971:2019 requirements and EU MDR expectations.
Yes. Participants receive course materials and 45-day replay access.
