The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
Although not a mandatory requirement of ISO 14971, it is a common practice in the medical device industry to use the P1, P2 approach for estimating the probability of harm (POH). In many cases,...
In this episode, we focus on some of the practical challenges in implementing a severity scale to analyze the risk of harm associated with medical devices. Industry practice is to use a 1-5 scale...
Estimating risk of harm for your medical device is a requirement of ISO 14971:2019. However several practical challenges make it difficult to accurately estimate the risk of harm. This is partly...
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