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For some reason it feels as if the requirement regarding competence is a surprise or an afterthought to many. I have seen time and again situations where risk management file maintenance has been delegated to newer/less experienced engineers, since the assumption is that it is a simple task. Unfortunately, ...

The Design Quality Assurance role is a really effective way of ensuring risk management is performed throughout the life of the medical device. When I was in that type of role (AQE at Stryker), it was simple to hand off/ensure the risk management file was maintained after launch by the post-market teams. ...

It sounds as if you are trying to do too much at once within the "policy for establishing criteria for risk acceptability" as described in the standard. As noted in ISO TIR24971:2020 "Medical devices- Guidance on the application of ISO 14971," the policy itself is intended establish a framework that ...

I think reducing the discussion of benefit-risk to a quantitative analysis or trying to shoe horn it into being expressed as a ratio runs the risk of misrepresenting the information.  Note that ISO 14971:2019 makes provision for a benefit-risk analysis to be performed in the event that a residual risk ...

Using ChatGPT for regulatory submissions sounds like a potential nightmare.  In the context of medical devices, the expectation is that the manufacturer evaluates suppliers, contractors and consultants "on the basis of their ability to meet specified requirements, including quality requirements" and ...