Expert in medical device standards and CE regulations
This expertise has been gained over 30+ years of working in various roles in the medical device industry, including 15 years as a notified body contract Lead Auditor for DEKRA.
Read more about usRob UdoConsultant
News
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19 december 2025Proposal for simplifying rules for MDR/IVDR
The proposal aims to simplify and reduce the regulatory and administrative burden associated with EU MDR (2017/745) and EU IVDR (2017/746), while ...
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27 november 2025
EUDAMED implementation deadlines Commission Decision (EU) 2025/2371
Commission Decision (EU) 2025/2371 makes EUDAMED mandatory. These are the key deadlines and considerations for manufacturers.
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18 december 2023
Position paper Medical Device Lifetime
The Team-NB Position Paper defines the lifetime of medical devices under the Medical Devices Regulation 2017/745. It addresses the lack of a specific ....
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