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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2 December 2022Submitting Technical Documentation under the MDR?
Submitting Technical Documentation? Read the Team-NB Position Paper on Best Practice Guidance for the Submission of TD under the MDR (5 Oct 2022, ver 1)
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15 September 2022Notified body capacity
The MDCG recognizes that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers ...
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27 June 2022
Manufacturers approach to the MDR bottleneck around May 2024
MDCG 2022-11: a position paper of the MDCG about how manufacturers of medical devices may approach the MDR certification bottleneck in May 2024
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