Risk management following EN ISO 14971 is a mandatory activity for any medical device manufacturer which must be established and actively be updated on a regular basis in order to comply with European medical device regulations. Risk management is intended to cover all aspects of medical devices, starting at product design and biocompatibility of raw materials, and ending at clinical investigations and post market surveillance activities. Manufacturers must not only consider their own products and product-related processes, but also must observe available literature data for substantially equivalent devices.
Risk management is both a prospective and retrospective process which requires regular activities: A prospective risk management plan must be prepared describing the risk management process and criteria on how particular risks will be evaluated later. In the course of a risk management meeting, designated participants will identify and evaluate risks relating to all applicable aspects of the medical device or medical device family under consideration. Finally, a risk management report is prepared which describes potential residual risks and concludes with positive risks vs. benefits ratio.
- Risk management plan
- Responsibilities for risk management
- Risk management criteria
- Risk management report