Course
has successfully completed the following online training course on 7 February 2025, titled:
Mandy Do
Introduction to Risk Management for Medical Devices and ISO 14971:2019
Peter Sebelius
Founder & CEO, Medical Device HQ AB
Course learning goals:
- Understand the overall process of risk management and how to create safe medical devices
- Be able to participate in performing risk analysis, risk evaluation and risk control according to ISO 14971:2019
- Be aware of different risk management tools, such as FMEA and P-FMEA.
This activity equates to 12 hours of CPD
The validity of the certificate and the qualifications of the course leader can be verified by contacting medicaldevicehq.com. Refer to certificate no 132668018
Certificate
Introduction to Risk Management for Medical Devices and ISO 14971:2019
Mandy Do
This online course focuses on risk analysis, evaluation and risk control. It covers an orientation of the risk management process according to the EN ISO 14971:2019 version of the standard as well as the standard’s relation to tools and techniques such as FMEA and P-FMEA.
Skills / Knowledge
- Medical devices
- Risk management
- ISO 14971
- requirements
- risk analysis
- risk evaluation
- risk control
- usability engineering
- FMEA
Issued on
February 7, 2025
Expires on
Does not expire