Why Should You Attend:
IEC 62366 is the international standard that covers the application of usability engineering to medical devices. This standard helps medical device manufacturers consider human factors by offering a standardized 9 stage process for analyzing, specifying, developing, and evaluating the usability of their medical device, and document the process and results. This standard would satisfy the human factors requirement of the US FDA. It presents a 9 step methodology to perform and document User / Human Factors Engineering, with a focus on the typical human user.
Areas Covered in the Webinar:
Who Will Benefit:
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 26 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles and book chapters (RAPS) in peer reviewed journals, conducted workshops and webinars worldwide. John is a graduate of UCLA.
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