The ACHIEVE Blog
Insights on risk management topics and tips and techniques for implementation.
Medical devices are heavily regulated across the world. In general, manufacturers are required to establish an effective Quality System to comply with regulatory requirements for continued market...
Analysis of post-market data is critical to ensuring continued safety and effectiveness of our medical devices. It is also a requirement of ISO 14971:2019. A common practice in the medical device...
ISO 14971 requires the top management to evaluate the suitability and continuing effectiveness of the risk management process for their medical device. But this evaluation is generally done rather...
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...
This week, we kicked off our Weekly Live Discussion Series! We talked about Hazard Analysis and why it becomes challenging if you try to combine it within a FMEA (Failure Mode Effects...
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