Expert in medical device standards and CE regulations
This expertise is gained in over 25 years working in various roles in the medical device industry, including 10+ years as a notified body contract Lead Auditor for DEKRA.
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News
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26 June 2020ISO/TR 24971:2020 Guidance on the application of ISO 14971
ISO/TR 24971:2020 ISO/TR 24971:2020 Guidance on the application of ISO 14971.
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19 June 2020EC publishes new version of Manufacturer's Incident Report
European Commission publishes a new version of the Manufacturer's Incident Report (MIR 2020).
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29 May 2020EC will begin making some Eudamed modules available next year
The EC will begin making some Eudamed modules available next year, according to an email to members of the Eudamed working groups.
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