The IEC’s 2015 usability standard for new medical devices (IEC 62366-1:2015 Part 1) addresses the growing concerns of regulatory agencies in the US and EU about how easily a person can interact with a system, product or procedure.
Engineering for optimal human use is vital to the FDA, with the agency mandating in guidance documents that manufacturers make medical devices and products so that human error is reduced and the products can be used intuitively.
This webinar, by expert speaker John E. Lincoln, will address the requirements of the IEC standard, as well as the non-regulatory tutorial/guidance of its companion, “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”.
The webinar will answer basic questions device manufacturers, start-ups, investors and other stakeholders have as to the basic medical device development process incorporating Human Factors/Usability Engineering and its documentation/files, in the U.S. and EU. You will also get an overview of the basic activities and documents to show compliance to this new standard as expected by both the U.S. FDA and European Union, and other governing bodies.
The session will provide an overview of:
Who Should Attend
Ask a question at the Q&A session following the live event 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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