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Validity : 30th Nov'21 to 10th Dec'21
Part 1, IEC 62366-1:2015, “Application of the new Usability Engineering Standard to Medical Devices”, defines a 9-stage process to analyze, specify, develop and evaluate the usability of a medical device as it relates to safety.This usability engineering (human factors engineering) process permits the manufacturer to assess and mitigate risks associated with correct use and use errors, i.e., normal use. It is also used to identify (but does not assess or mitigate) risks associated with abnormal use.
Also not intended to address purposeful / intentional misuse of a device.
Part 2, IEC/TR 62366-2:2016, “Guidance on the application of usability engineering to medical devices”, contains information to assist in complying with Part 1.This TR is not intended for regulatory purposes use. It has no requirements and only provides guidance / tutorial information, including more detailed descriptions of usability engineering methods. It has more general applications, and goes beyond just the safety related aspects of user interfaces.
Part 1 is the focus, containing the regulatory requirements of IEC 62366. It presents a format for conducting and then documenting the use engineering process in a way acceptable to the US FDA and the EU’s MDR, for device submissions and regulatory review / inspection.
One of our newest webinars. IEC 62366-1:2015 and IEC/TR 62366-2:2016 provide a process and template for performing and documenting the key elements in use engineering (EU) and human factors engineering (US FDA). Use engineering should be performed in conjuction with product risk management under ISO 14971, both as part of design control, 21 CFR 820.30 and design and development planning, ISO 13485:2016 7.3, during R&D for a new device.This webinar breaks down and defines the use engineering process, its 9 defined stages, and its documentation to meet both US FDA and EU MDD /MDR requirements.Interfaces of unknown province is also discussed.
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 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.