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.
In our last two articles, RM 5 – Assessing Severity and RM 6 – Estimating Probability of Occurrence of Harm, we discussed approaches to develop values for these two elements of risk and the challenge of completing these assessments/estimates. This article takes the next step to address the question: Are we, as a company, willing to accept the risks associated with our device given the benefits that a patient is likely to receive? This article (Part A) provides a review of the standard approach. A second article (Part B), will provide our thoughts on the challenges.