Hello and welcome to the module "Risk management of medical devices ISO 14971 version 2019"
Goal of the module
Risk control of medical devices (ISO 14971) to be able to:
- reduce risks
- obtain benefits greater than risks
- manage risks throughout the life cycle of the medical device
With this module you will learn about the ISO 14971 standard and
- its content
- its principles
- its requirements
- its stakes
You will become familiar with
- process approach
- general requirements of the life cycle of medical devices
- risk analysis
- risk evaluation
- risk control
- overall residual risk
- risk management review
- medical device terminology
- case studies
At the end of the module you will know how to
- interpret the requirements of the ISO 14971 standard
- take part in the development of the risk policy
- take part in the implementation of the documentation system
- evaluate the ISO 14971 certification project
How to be more effective during e-learning
- choose the hours of the day (or night) when you feel best ready to learn
- ask people around you not to disturb you during your training
- stay focused during the training
- take notes
Where to start?
it is best to start from the beginning. The multiple choice test (MCT) at the beginning will help you to understand where you are in relation to the module.
To access the final MCT, you must have passed the 5 MCT's with success (note: 15 or more out of 20). Take your time and do not be afraid to go back and start the MCT again. The certification audits are based on clauses 4 to 8, but the first three chapters of the module will help you easily acquire the material.