About Risk Management - ISO 14971:2019
Risk Management – i.e. the planning, analysis and assessment of risks related to a medical device is a requirement in MDR and for premarket product approval in for example EU USA and Canada.
Goal:
To give a basic understanding and give some tools on how to run and benefit from the risk management process.
Who benefits:
Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).
Program:
Introduction to the ISO 14971
• Background and regulatory requests
• The risk management process
- Risk Management Plan (RMP)
- Acceptance criteria
- Risk Analysis
- Risk Management Report
• Process interfaces and organization requirements
Risk analysis
• What kind of risk analysis and technique?
• Work shop RMP and risk analysis
• Presentation work shop
Discussion and questions