User / Human Factors Engineering Under IEC 62366-1, -2
Instructor:
John E Lincoln
Product ID: 705111
Training Level: Advanced
- Duration: 90 Min
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:
- Key parts of IEC 62366-1:2015 and -2:2016 – Use Engineering /
- FDA’s Human Factors Engineering
- IEC 62366m Part 1 focuses on “what”, Part 2 on “how”
- More harmonization – US FDA, ISO 14971 and IEC 62366
- Role in Design Control (21 CFR 820.30)l, Design and Development Planning (ISO 13485 7.3)
- Planning requirements
- The defined engineering process
- “Interface” defined
- User interface considerations
- Formative and Summative Evaluations and their Verification and Validation Equivalents
- Software considerations
- Suggested documentation – a Use Engineering File.
Who Will Benefit:
- Senior Management
- Middle Management
- QA/RA
- Operations
- Production
- Engineering
- Marketing
- Medical Device Consultants
John E Lincoln
Principal, J E Lincoln and Associates
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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