Past event: Virtual Seminar on Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

4-Hour Virtual Seminar

This Seminar 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 on recommended implementation considerations will be briefly considered, with the focus on IEC 62366-1, the basic methodology.  the webinar willshow 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. Document under design control.

Why you should attend

Both the U.S. FDA and the EU's MDR require consideration of use engineering / human factors engineering as part ofnew or changed product development, especially in R&D. Companies must be proactive in evaluating a device's interface inorder 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..  

Who Will Benefit

  • Senior Management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • R&D and Engineering
  • All Personnel Tasked with product develop, use / Human Factors / Hazard Reduction and Problem Solving
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

The full agenda is not yet available for this event.
Follow this event to receive an alert when the agenda becomes available.

Time: 08:00 AM PDT | 11:00 AM EDT

  • 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
  • Importance of concurrent risk management.


The venue is not yet available for this event.
Follow this event to be informed when the venue is available and stay informed on other changes.

Event details
Organizer : Global Compliance Panel
Event type : Training Course
Reference : ASDE-24401