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Katharina Gruchenberg
Team Leader Biocompatibility and Materials of Animal Origin at TÜV SÜD Product Service GmbH


Katharina Gruchenberg is Team Leader Biocompatibility and Materials of Animal Origin at the Notified Body TÜV SÜD. She is responsible for a team of Biocompatibility Experts who are assessing biological safety evaluations according to ISO 10993 series and MDD / AIMD / MDR mainly for class III medical devices. Katharina herself is also a Biocompatibility Expert with many years of experience in biocompatibility assessments. From her former work at a preclinical CRO she also has practical experience in biocompatibility and toxicology testing according ISO 10993 series and OECD guidelines, mainly in vivo studies such as irritation / sensitization, implantation, acute to chronic systemic toxicity.

Agenda Sessions

  • Experiences working with the EU MDR and ISO 10993