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course med DNV Business Assurance
Risk Management - ISO 14971:2019
Pris pr. deltager
Kursus
6.800,00 DKK
306,00 DKK
I alt ekskl. moms
7.106,00 DKK
25% moms
1.776,50 DKK
I alt inkl. moms
8.882,50 DKK
Se tilgængelighed
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
Foredragsholder: DNV Business Assurance
Varighed: minutter
Sprog: Dansk
Tilgængelighed:
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