Matthias Käser is a medical device regulatory consultant and former FDA/CDRH reviewer with more than two decades of experience in the development and regulatory evaluation of active medical devices under 21 CFR 820 and ISO/IEC frameworks. He holds a Dipl.-Ing. (Electrical Engineering) from the University of Karlsruhe and an International MBA from the Stuttgart Institute of Management and Technology, including exchange programs at Pepperdine University, Bocconi University, and National Chengchi University (NCCU) in Taipei.

For four years he served as a subject matter expert supporting FDA/CDRH's Office of Health Technology 1 (respiratory, anesthesia, and sleep devices), where he reviewed over 250 submissions including 510(k), PMA, IDE, Q-Submissions, and recalls. His focus was software, cybersecurity, interoperability, and electrical safety/EMC, across traditional devices, SaMD, and AI/ML. He reviewed premarket cybersecurity submissions from the earliest days of Section 524B, contributed to FDA guidance documents, and trained FDA staff on software and cybersecurity requirements. That work gives him a direct view of what reviewers look for, and insight to where submissions actually fail or get delayed.

Before CDRH, Matthias spent 17 years at Philips in Germany and the US. He was DHF owner and program manager for the IntelliBridge connectivity platform, which received a standalone 510(k) clearance, and he managed the external software suppliers and SOUP/OTS documentation behind 10+ interface releases per year within an ISO 13485 QMS. He is an active participant in the IEEE 11073 standards committee and speaks at industry conferences including MEDevice Silicon Valley and MD&M West.

At exFDA Consultants, Matthias helps medical device and IVD manufacturers develop regulatory strategies and technical documentation that align engineering evidence with FDA expectations. His work focuses on submission strategy, IEC 62304 software lifecycle documentation, cybersecurity and threat modeling, ISO 14971 risk management, translating user needs into system requirements, and electrical safety and EMC compliance. In one case, an IVD program had been scoped to IEC 60601-1 when IEC 61010-1 and IEC 61010-2-101 were applicable standards. He is a native German speaker, fluent in English, and advanced in French.