Wolfgang Schwaiger is a Clinical Evaluations Manager with 11+ years of experience at the intersection of medical devices and biotech, combining a PhD in Biochemistry and Molecular Biology with hands-on regulatory and quality leadership. He has led clinical evaluations for cochlear and vestibular implants under MDR, translated surgeon-driven ideas into commercial devices as CTO, and acted as Qualified Person for ATMP production and validation. Comfortable across the full product lifecycle, he writes technical documentation to MDR standards and fuses risk management, post-market data and clinical evidence into robust risk–benefit assessments. His background in both regenerative medicine and device prototyping gives him a rare, practical view of combination products and their converging regulatory landscapes. Known for turning sketches and lab concepts into scalable, compliant products, he balances scientific rigor with pragmatic commercialization.
11 years of coding experience
PhD, Biochemistry and Molecular Biology, PhD, Biochemistry and Molecular Biology at Leopold-Franzens Universität Innsbruck / University of Innsbruck
Eberhard-Karls-Universität Tübingen / University of Tuebingen
Contributions:4 releases, 8 commits, 1 PR in 6 months
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