Matthew Strege

Matthew Strege

IEC 60601

Matthew is part of the US Regulatory Affairs team providing strategic perspectives from a regulatory authority’s point of view having worked for leading Notified Bodies in both a safety testing capacity and regulatory technical specialist capacity. Areas of expertise include medical device and in-vitro diagnostic device safety test planning, standard interpretation and application, technical documentation preparation, and global regulatory strategy.

Matthew has over 15 years of experience testing medical devices and in-vitro diagnostic devices and over 4 years reviewing technical documentation for compliance with global regulation. His experience and knowledge spans an international level, having had global responsibilities in US, Europe, and Japan, testing and reviewing active devices for standard conformity and CE Marking certification for a variety of medical devices (class I, IIa, IIb and class III).             

Matthew has a BSc degree in Bioengineering from the University of Illinois at Chicago, and a MSc degree in Biomedical Engineering from Northwestern University.

He started out his career as a project engineer at Underwriters Laboratories (UL) in Illinois. For UL he moved to California after a year, starting in medical device testing (IEC 60601). In 2003 he joined TUV Rheinland in Japan to become their Head of Medical Safety Testing. In this function, he has become an expert in all aspects of electrical safety testing for both medical devices (IEC 60601 standard) as well as in-vitro diagnostic equipment (IEC 601010 standard). As Head of Medical Safety Testing he was responsible for maintaining and expanding accreditations, training and qualifying engineers, providing technical expertise to quality auditors during MDD Notified Body audits. He also developed services for usability engineering and software development and has provided extensive training on these concepts.  He spent 11 years in that function before moving back to the US to join BSI Notified Body as Scheme Manager and Technical Specialist for active medical devices including software. He managed CE certification schemes under the MDD, conducted onsite and offsite reviews of technical files including clinical evaluations, addressed strategic questions of his clients, participated in unannounced audits and provided training and mentoring of new staff.

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