Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

This webinar will provide valuable guidance to regulated companies in development and implementation of Use Engineering / Human Factors Engineering using the 9 stage model in IEC 62366-1. IEC 62366-2 recommended implementation considerations will be briefly considered, with the focus on IEC 62366-1, the basic methodology.

The webinar will show when and how these tools are incorporated into R&D design control, risk management, validation, root cause analysis, CAPA / falure investigations, GMP auditing, and liability reduction.

Unlike risk management, use engineering may not always be necessary, depending upon the user interface under review. Use engineering is designed to reduce product risk, increase intuitive product use, reduce liability, and less chance of recalls.

Why Should You Attend:

Both the U.S. FDA and the EU's MDR require consideration of use engineering / human factors engineering as part of new or changed product development, especially in R&D.

Companies must be proactive in evaluating a device's interface in order to design for almost intuitive use, reducing product risk, and increasing product safety.

When it must be used and where such usage may not be required: When used, companies have often not provided the full documentation for the defined nine stages of use engineering to prove compliance and assist product engineers in refining the design to increase usability and reduce use risk.

Areas Covered in the Webinar:

• IEC 62366-1 and -2 overview
• The 9 key requirements of IEC 62366-1 and -2
• UOUP
• Part 1 focuses on “what”, Part 2 on “how”
• Key is the" Interface" - What is it?
• When and how to incorporate into product development
• Planning
• A clearly defined process for US CGMPs and ISO 13485 compliance
• Incorporation into the design and development (R&D) phase

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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.

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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.