Qserve Group is pleased to announce that Matthew Strege has joined Qserve to further expand its capabilities in supporting the medical device industry worldwide. Matthew has a wealth of experience on active medical devices, including software as a medical device, and usability. Matthew joins us from BSI, one of the largest Notified Bodies, where he has been a Scheme Manager and Technical Specialist for many US and internationally based medical device companies over the last few years.
He started out his career as a project engineer with the international compliance services group at Underwriters Laboratories (UL) in Illinois. For UL he transferred to California after a year, to start medical device testing (IEC 60601).
In 2003 he joined TUV Rheinland Japan and became 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 61010 standard). As Head of Medical Safety Testing he was responsible for maintaining and expanding accreditations, training and qualifying engineers, and 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 for his clients, participated in unannounced audits and provided training and mentoring of new staff. After 4.5 years he now joins Qserve to use his expertise ‘on the other side of the table’ for our clients.
Matthew has a Bachelor of Science in Bioengineering from the University of Illinois at Chicago and a Master of Science in Biomedical Engineering from Northwestern University in Illinois. He is a native English speaker and additionally speaks Japanese and some German.
Quote from Keith Morel, VP Regulatory Compliance
“I am very excited that Matthew has joined us. He brings wealth of experience on active medical devices/IVDs and software with him, which will complement and enhance our current teams’ skill sets. With his background we will be better able to serve our many clients who have active devices, software embedded within their medical device, web-based services, human-machine interfaces or apps to meet EU MDR requirements, as well as those for US FDA, Japan, Canada and China.
These days, such technology seems almost ubiquitous, with so many companies having such technology as part of their medical device/IVD, that Matthew’s understanding of leading Notified Bodies and Test Lab expectations, and the ‘nitty-gritty’ of how they do their work, will be an invaluable asset to our clients as they navigate the increasingly complex regulatory environment for such devices. His expertise could help our clients in a variety of ways from high-level strategy in developing pragmatic and compliant testing programs, or how best to address cybersecurity concerns or software development processes, to tactical navigation of individual tests to meet IEC 60601, or helping them understand how Notified Bodies will audit to the requirements of the MDR, for example. I couldn’t be happier to have Matthew join our team and I look forward to integrating his expertise and experience into the holistic solutions we offer our clients!”
About Qserve Group
Qserve’s mission is to support all medical device and in-vitro diagnostics manufacturers with a practical approach, translating existing regulations to understandable requirements. We serve to guide manufacturers in gaining and maintaining compliance as well as conducting clinical studies as a CRO to ensure safe and quality devices in the most streamlined way possible. Qserve’s global team combines its regulatory and clinical knowledge and experience in the medical device industry, sharing more than 900 years’ worth of combined expertise in the medical field. Having teams in the EU, USA, and China provides a global footprint for global regulatory, clinical, CRO and quality services.