Since 1990, FDA has required medical device manufacturers to follow design controls. Outside the US, the EU MDR (formerly MDD) include similar requirements as well.
Yet, although manufacturers have design control processes in place, they are not always effective as failure to follow design control requirements is commonly cited in FDA 483’s and warning letters.
Clearly just having design controls in place and understanding what the regulation says is not enough!
We must also understand what design controls are trying to accomplish, i.e., why they exist, in order to avoid problems.
At the end of the day, design controls should not be about a hard and fast set of rules… rather, it’s about understanding the intent and approaching the process in a logical and systematic fashion. In other words, don’t just follow the rules… think!
Using the Case Study Approach, participants will gain a working understanding of:
Upon completion of this webinar, attendees will have an understanding of the design control “framework” and recommendations to effectively meet their requirements.
Emphasis will be placed not only on regulatory aspects but on effective design strategy, which is very important to avoid spending unnecessary time and money on an ineffective design control process.
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Michael Drues, Ph.D., is a regulatory strategy consultant specializing in designing novel regulatory strategies to bring new and innovative medical products to market and in developing effective communication strategies between companies and regulatory agencies to minimize time to market and avoid delays.
His consultancy, Vascular Sciences is a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense. If you'd like to learn more click here.
Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University. He works with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration, Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services and other regulatory and governmental agencies around the world.
Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the FDA, Health Canada, the US and European Patent Offices, CMS and other regulatory and governmental agencies around the world.
Finally, Dr. Drues is an Adjunct Professor of Regulatory Affairs, Medicine and Biomedical Engineering at several universities and medical schools. He regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Medical Device Regulatory Affairs and Product Development, Combination Products and Pathophysiology.