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Matthew Krueger, MS, RAC (US) (he/him/his)

Principal Consultant
Biologics Consulting Group, Inc.
Alexandria, Virginia

Matthew Krueger has over 20 years of experience working in the regulation of medical devices. He has over 15 years of experience at the FDA working in the Center for Devices and Radiological Health (CDRH) starting in the Office of Device Evaluation reviewing pre-market submissions. He then worked in the Office of Compliance as a branch chief supervising the regulation of manufacturing associated with the Quality System Regulation as well as enforcement related to the Quality System Regulation, recalls, and promotion and advertising. In 2018, when CDRH reorganized, he supervised a team in CDRH's Office of Product Evaluation and Quality working on both pre-market and post-market review of neurology devices. He has worked as a consultant for medical device regulation for the past 6 years at Biologics Consulting starting as a Senior Consultant and now as a Principal Consultant. He works with clients on a variety of both pre-market review submissions and post-market matters including establishment of Quality Systems, FDA inspections, and enforcement actions.

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