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Maxim Shkolnikov

Technical Manager, Medical Device International
TÜV NORD CERT

Maxim Shkolnikov has a master's degree equivalent in human and animal physiology from the Lomonosov Moscow State University and an engineer degree in medical technology quality and safety engineering from the Lübeck University of Applied Sciences. He has over 15 years' experience in establishing and leading of ISO 13485-based regulatory conformity assessment schemes, such as CMDCAS, MDSAP and MDR, in certification/ auditing/ notified bodies. As regulatory manager of an MDR-designated notified body and an MDSAP auditing organisation, Max has been participating in or leading task forces developing consensus positions and guidance for the conformity assessment frameworks. He is currently working at TÜV NORD CERT as technical manager focussed on MDR and is leading the NBCG-Med/Team-NB task force on the mapping of the QMS audit requirements of MDR/IVDR to MDSAP.

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