Karin is a well-recognized medtech expert with extensive knowledge in the development of medical devices and in vitro diagnostics (IVDs). Under Karin’s leadership, the SFL team will support clients developing and manufacturing medical devices, IVDs and combination products to ensure continuous marketing of their products under the medical device regulation/in vitro diagnostic regulation MDR/IVDR.
Before joining SFL, she led a Swiss notified body for many years, where she conducted numerous conformity assessments of medical devices (all classes), combination products and IVDs and held responsibility for CE certification decisions.
In addition to her product expertise, she has extensive knowledge of Quality Management Systems, covering all aspects of developing, training, implementing and maintaining ISO 13485 certification and auditing against harmonized standards. Since 2010, Karin is an authorized auditor for the Canadian Regulation (SOR-98/262).
As a member of the NB MED team, Karin has actively worked with the European Commission on various guidelines as well as the MDR/IVDR. Furthermore, she worked closely with Competent Authorities on various projects, including classification of borderline products.
Karin will lead the working group at the Medtech & Pharma Platform (MPP) concerning the new MDR and IVDR, to ensure that the interests of key stakeholders and MPP members are conveyed to the EU commission for the upcoming delegated and implementing acts.
She is also an active member of the SIT group at Swiss Medtech, SAQ Fachgruppe Medizinprodukte and Technical Committee TC 210 for medical devices.
Karin holds a PhD in Biology from Technical University Munich and Max-Planck-Institute for Biochemistry in Martinsried, Germany.
SFL Regulatory Affairs & Scientific Communication Ltd.