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.