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.
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News
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18 december 2023Position 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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24 maart 2023Extension of the MDR transitional period
New EU Regulation 2023/607 came into force on March 20, 2023, regarding the extension of the transition period for the MDR.
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17 februari 2023
Extension of the Medical Devices Regulation (MDR) transition
The European Parliament has voted to extend the (MDR) transition periods to avoid a shortage of life-saving products in the EU.
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