Course
has successfully completed a blended learning training course, with approximately 20 contact hours, on risk management, titled:
Katie Bennett
Risk Management for Medical Devices and ISO 14971:2019
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Peter Sebelius
Founder & CEO, Medical Device HQ AB
The learning goals are: a) To understand the overall process of risk management and how to create safe medical devices. b) To strengthen the ability of participants to independently perform risk analysis, risk evaluation and risk control. c) To establish and increase knowledge on risk management tools and their differences, such as FMEA and P-FMEA.
The validity of the certificate and the qualifications of the course leader can be verified by contacting medicaldevicehq.com. Refer to certificate no 50739593
Certificate
A score of 98.0% was achieved on the final online exam on 13 April 2022
Katie Bennett
This blended learning course is designed to teach you how to work with risk management according to the requirements of ISO 14971:2019. It covers all parts of the risk management process and provides an orientation on ISO 14971 risk management's relation to tools and techniques such as FMEA and P-FMEA.
Being a blended course, it combines the 'Introduction to Risk Management for Medical Devices and ISO 14971:2019' online course with a live virtual 'practical' classroom session. This enables the theory to be learnt first and then put into practice, which helps embed the learning.
Skills / Knowledge
- Medical devices
- Risk management
- ISO 14971
- FMEA
- FTA
- Risk analysis
- Risk control
- Risk evaluation
- P-FMEA
Issued on
May 5, 2022
Expires on
Does not expire
Evidence
98%