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.
Read more about usRob UdoConsultant
News
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24 July 2020MDCG 2020-13 clinical evaluation assessment report
MDCG 2020-13 clinical evaluation assessment report, a core requirement of the Medical Device Regulation (EU) 2017/745 (MDR).
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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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