Medical device developers cannot fully comply with standards like IEC 62366 on usability engineering, ISO 10993-1 on biocompatibility, and IEC 60601-1 on electrical safety unless they also comply with ISO 14971. This international standard for risk management for medical devices provides a framework for manufacturers to demonstrate the safety of their devices. But what are the requirements of this standard?
Join award-winning consultant and author Bijan Elahi and Jama Software’s Rene van Popering for a half-day seminar on risk management for medical devices and the expectations of ISO 14971.
With the release of EU MDR in 2017, new changes were introduced that affect risk management for medical device manufacturers. In this seminar, we will review the requirements of ISO 14971 and how to efficiently ensure compliance. We’ll also cover the new expectations of EU MDR from a risk management perspective.
Rene van Popering
In this seminar, you’ll learn:
- The importance of risk management
- How to develop a compliant and safe medical device by controlling risk
- The landscape of risk management standards
- The vocabulary, language, and requirements of risk management and ISO 14971
- How risk management adds value to product development
- The impact of EU MDR on medical device risk management
- Automating traceability into a live system of record
- Streamlining workflow and strengthening collaboration when developing medical devices
- Risk assessment and design validation using Jama Connect™
- 09:00 – 09:30 Welcome coffee
- 09:30 – 11:30 Presentation by Bijan Elahi & QA
- 11:30 – 12:30 Presentation by Rene van Popering & QA
- 12:30 – 13:30 Lunch and networking
- 13:30 – End of the program