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Lisa Schälter, MSc (she/her/hers)

Business Area Lead IVD
Consultys Medical GmbH

Lisa Schälter holds a Master of Science in Molecular Life Science from Friedrich-Alexander-Universität Erlangen-Nürnberg and has extensive experience in regulatory affairs and quality management within the medical device and in vitro diagnostics (IVD) sectors.

She began her career at be-on-Quality GmbH in 2019 and progressed through roles of increasing responsibility. Since November 2024, she has been the Business Area Lead for IVD & Combination, Tissue and Substance-Based Medical Devices.

Lisa has successfully supported the certification and approval of multiple Class I, IIa, IIb and III medical devices and Class A, B, C and D IVDs, as well as the implementation and certification of several quality management systems. Her expertise covers MDR (2017/745), IVDR (2017/746), performance evaluation, post-market surveillance, biological evaluation, usability engineering, and risk management in accordance with ISO 14971.

She was also an instructor for Siemens Healthineers’ IVDR training course, gives lectures on regulatory affairs topics at the Friedrich-Alexander-Universität Erlangen-Nürnberg and regularly contributes her expertise to industry projects, with completed assignments ranging from technical documentation for Class D IVDs and Class III devices to biological assessments, software as a medical device documentation, and supplier audits.

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