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IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 -- Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”. Its 9 Stages provide a repeatable process for performing UE and documenting the process and results in a UE File. These address an on-going concern by regulatory agencies in both the US and EU, human factors engineering, or it’s synonym, usability engineering. Usability can be defined as “the ability for a human to interact easily and relatively error-free with a system, product or procedure.” The FDA views human factors engineering as mandated to reduce user error and make medical products use as close to intuitive as possible, especially since 2000. In one of their guidance documents on the subject, it states: “CDRH considers human factors testing a valuable component of product development for medical devices”. This webinar will focus on the two parts of the standard and it’s key requirements and application to medical devices.
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, 27 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 and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.