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    • Market Access
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      • And more…
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      • ISO 13485 audits
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      • Quality management system as a service
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      • Performance evaluation of IVDs
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      • FDA relevant documents
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November 2022


Medical Device Coordination Group (MDCG)

By Markus GerhartNovember 25, 2022Leave a comment

The Medical Device Coordination Group (MDCG) is an expert panel required by the MDR and IVDR. The MDCG is sometimes confused with another coordination group or with expert panels. You can find out how these groups are differentiated here. Read this article to find out how you are affected by the output of the MDCG’s…

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Regulation as Code: The end of regulation as we know it

By Prof. Dr. Christian JohnerNovember 22, 2022Leave a comment

Regulators still publish laws and regulations as texts. Just as it has been for thousands of years. Regulation as Code represents a radical paradigm shift away from this practice. Is it possible to transform laws into algorithms? Why should anyone want to do this? How should you get ready for this as a regulator, manufacturer, authority, or…

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