This webinar by expert speaker John E. Lincoln will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes/goals, as well as the two different device classification schemes.
John will present an overview of the basic activities and documents to show compliance to design control and meeting “essential requirements” in addressing the regulatory document hurdles to get a new medical device to market. He will cover requirements under various regulatory agencies worldwide, with emphasis on the U.S. and the European Union. John will also answer basic questions device manufacturers, start-ups, investors and other stakeholders have on basic medical device development documentation and major milestones to get a new medical device to market in the U.S. and EU.
Who should attend:
At the Q&A session following the live event, ask a question and get advice unique to your situation, directly from our expert speaker.
- Edwin Waldbusser,
- Dr. Charlie Sodano ,
- Joe Keenan, MBA, CSP
- Charles H. Paul,
- Dr. David Lim, Ph.D., RAC, ASQ-CQA
- Dr. Jerry Lanese,
John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...
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