Course
has successfully completed the following online training course on July 3, 2024, titled:
Mirva Kallio
Advanced Risk Management for Medical Devices and ISO 14971:2019
Peter Sebelius
Founder & CEO, Medical Device HQ AB
Course learning goals:
- Evaluate the effectiveness of risk management processes
- Analyse conformity to regulatory requirements of risk management
- Recommend different approaches to risk management for different situations
The validity of the certificate and the qualifications of the course leader can be verified by contacting medicaldevicehq.com. Refer to certificate no 107841553
Certificate
Advanced Risk Management for Medical Devices and ISO 14971:2019
Mirva Kallio
This online learning course is designed to provide you with a much deeper understanding of the concepts covered in the introductory risk management course. It delivers more information on the risk management process and procedure, and risk management planning according to the requirements of ISO 14971:2019.
It also provides an in-depth review of the different concepts of risk, what risks to include in the risk assessment, the risk control process, and how the required traceability can be achieved.
Skills / Knowledge
- Medical devices
- Risk management
- ISO 14971
- FMEA
- FTA
- Risk analysis
- Risk control
- Risk evaluation
- P-FMEA
Issued on
July 3, 2024
Expires on
Does not expire