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Now hiring at MEDIcept - Sr. Regulatory Consultant
Hi Everyone,
In case you haven’t heard of MEDIcept, we are a small Consultancy and CRO for the Medical Device Industry. Due to popular demand of SaMD and SiMD experience, our Regulatory team is growing! It is a salaried position with benefits. Please reach out if you would like to learn more! nradoux@medicept.com
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I have also been hoping for some more information on this and guidance on how to raise this with clients so we can adequately anticipate any impact to testing strategies?
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I see that ISO 10993-1: 2025 is under publication and will be releasing soon, and that the US voted “NO” for the changes. I can’t find any intel about what specific clauses the US objected to other than “cumulative use” (how repeated uses of a device add up in exposure) which will significantly revise (increase) the contact duration and…
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