According to ISO 14971, legal manufacturers are required to perform a Risk Analysis for their medical devices. However, the expectation is that they also perform Failure Mode and Effects Analyses (FMEAs) regarding design, usability, software, and processes.
A Risk Analysis and an FMEA differ in what they analyse, and consequently, in their applied methods.
In the 5-minute guide below, our Head of Quality Dr. Dirk Hüber shares a useful overview of the key differences to help ensure your risk analysis processes stay efficient and effective…
Do you have a risk management challenge? Our Quality team is ready and happy to help – simply get in touch to start the conversation.
