Use/Human Factors Engineering Under IEC 62366-1, -2
John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a
consulting company with over 35 years of experience in U.S. FDA-regulated
industries, 21 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). John has prior experience in military, government,
electronics, and aerospace. He has published 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 periodically writes for the Journal of Validation Technology. John is a graduate of UCLA.
This webinar will discuss the 9 stages of use engineering required by IEC 62366-1. It also briefly reviews IEC 62366-1 / IEC/TR 62366-2 - Medical Devices package, which provides assistance with the proper use of medical devices as it pertains to human risk factors.
The standard specifies safety related processes to analyze, develop, and evaluate the usability of medical devices and is applicable to "normal" medical devices used and is supported with guidance information. The 9 stages of use engineering are reviewed in detail to provide a step-by-step approach to the administration and documentation of this mandated activity. These defined steps provide assistance with the proper use of medical devices as it pertains to human risk factors. The standard specifies safety-related processes to analyze, develop, and evaluate the usability of medical devices. Safety-related processes to analyze, develop, and evaluate the usability of medical devices. It presents a process and documentation requirements in a format acceptable to both the US FDA and the EU MDR, under the Design Control / Design and Development Planning requirements of both 21 CFR 820 and ISO 13485 7.3. The user interface is defined, as well as formative and summative evaluations and the other supporting steps required by the standard.
- Key parts of IEC 62366-1:2015 and -2:2016
- Part 1 focuses on “what”, Part 2 on “how”
- Closer ties to ISO 14971, Medical Device Risk Management
- Closer adherence to US FDA guidance; more harmonization
- Planning requirements
- Hazardous situations, intuitive use, safe design issues
- Defined engineering process - the 9 stages
- User interface considerations
Course Level - Intermediate
Who Should Attend
This webinar will provide valuable guidance to regulated companies in:
- Design and Manufacturing Engineers
- Computer programmers and testers
- Management and Supervisory Personnel
Why Should You Attend
Human factors design is a requirement of the US FDA and EU’s MDR. IEC 62366-1:2015, “Application of the new Usability Engineering Standard to Medical Devices”, defines a 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. It is not intended to address purposeful/intentional misuse of a device. Special emphasis will be placed on section 5 of the standard which lists the 9 stages of the use engineering process, and how it is to be implemented and then documented in a Use Engineering File, as part of the Design Control process. How to address a user interface of unknown provenance is also discussed.
Human factors / Use engineering methods provide analysis of a device’s “user interface” to facilitate the proper use of medical devices as it pertains to human risk factors.