MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.
Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.
To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.
Our last article, Determining Risk Acceptability (RM7 – Parts A and B), described the standard approach (i.e., ISO 14971) for evaluating medical device risk and assessing the acceptability of those risks. We also identified some challenges that you will face when implementing the standard, and presented some approaches for overcoming those challenges. This article addresses Risk Control – i.e., what to do when you find you identify unacceptable risks.