Beat Keller is a Regulatory Affairs and Quality Management Specialist with a focus on active, non-implantable medical devices. His expertise lies in ensuring compliance with IEC 60601, IEC 62304, and ISO 80601, supporting manufacturers in meeting regulatory requirements for swift market access.

With a strong background in risk management, technical documentation, and conformity assessment, Beat helps companies navigate the complexities of Swiss, EU and US regulations. He is actively engaged in standardization work at national and international levels, serving as Co-Convener of the Swiss Conformity Assessment Working Group (mirror committee to ISO CASCO) and Secretary of IEC TC 62A/MT49, where he contributes to the development of IEC 62304.

Beat’s approach is pragmatic and solution-oriented, with a clear focus on delivering compliant medical devices for efficient market entry.