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Posts by Michael Drues, Ph.D.

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

Michael Drues, Ph.D., is president of Vascular Sciences, an education, training, and consulting company offering a broad range of services to medical device, pharmaceutical, and biotechnology companies. He has worked for — and consulted with — leading medical device, pharmaceutical, and biotechnology companies ranging in size from start-ups to Fortune 100s. Drues works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the U.S. and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS), and other regulatory and governmental agencies around the world. He is also an adjunct professor of medicine, biomedical engineering, and biotechnology at several universities and medical schools, teaching graduate courses in regulatory affairs and clinical trials, clinical trial design, medical device regulatory affairs and product development, combination products, pathophysiology, medical technology, translational medicine, and biotechnology. He received his B.S., M.S., and Ph.D. degrees in biomedical engineering from Iowa State University. You can reach him at mdrues@vascularsci.com or on LinkedIn.

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Establishing a QMS

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong

Michael Drues, Ph.D.
September 28, 2015
Risk assessment and risk management in the medical device industry typically start with a brainstorming session. Read More

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