Published Date: July 20, 2022
This presentation will provide an overview of considerations regarding biological risks from primary packaging materials for CE marking of combination products.
Furthermore, combination products falling under the Art 117 MDR requiring a NBOp (regulatory background and common pitfalls) will be discussed.
Learn more about the presenters below.
Regional Manager Focus Topics (Article 117 & Annex XVI) – TüV SüD
From her educational background Dr. Hofmann is a Biologist. It quickly became obvious to her that her main interest was in the biomedical area. That´s why she performed her PhD at the Helmholtz Research Centre of Munich in cooperation with the Technical University of Munich in the field of Toxicology with focus on risk analysis. During this time, she increased her expertise in Toxicology by attending several courses of DGPT the association of toxicology specialists. After gaining several years of experience in the pharmaceutical industry at companies like Novartis she joined TÜV SüD in 2016 as an auditor and senior product specialist. Prior to that, she was leading a team of experts and auditors for non-active medical devices. Currently, she is the Regional Manager for the focus topics Article 117 and Annex XVI products in the DACH & Nordics region. This is really a perfect match for her because she can combine her passion for biomedicine and her experience in medical devices that she gained over the past years.
Expert Biocompatibility – TüV SüD
Dr. Katharina Weidmann received a Diploma and PhD in Biology. In addition to her academic expertise, she has five years of work experience as a study director, working on in vivo Pharmacology and Toxicology for a contract laboratory outside of Tüv Süd. She also worked on Medical Device testing according to ISO 10993 series. In 2015 she joined Tüv Süd Product Service GmbH as a Biocompatibility expert and this has been her field of expertise ever since.
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