Bertram Mihm

Bertram Mihm has extensive experience in medical technology and regulatory affairs. Currently serving as Team Lead Medical at CSA Group since August 2012, Bertram is responsible for the evaluation of active medical devices in accordance with international standards. Prior roles include Certification Engineer at CSA Group and Verification Engineer at Ondal Medical Systems GmbH, where responsibilities included compliance assessments and the development of product specifications aligned with various standards, including ISO 14971 and IEC 60601. Additionally, experience as a Material and Production Planner at Ondal USA Inc. involved technical order clarification and production planning, and earlier, as a Quality Assurance professional at Ondal Industrietechnik GmbH, Bertram contributed to material management and quality audits. Educational qualifications include a managerial degree in Regulatory Affairs from TÜV SÜD Akademie and several technical certifications in engineering and business management.