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, along with the two different device classification schemes, updated to the new ISO 13485:2016 requirements, ‘How to address ISO 14971 Risk Management File’, and ‘IEC 62366 Usability Engineering File requirements.’
In this session, John will present an overview of the documents and explain what you need to know to comply with design control and meet the essential requirements. He will also address the regulatory document hurdles to get a new medical device to market under various regulatory agencies worldwide. This session will focus on the U.S. 21 CFR 820.30, and the European Union (and related) ISO 13485:2016 7.3 requirements.
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.
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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