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The New Usability Engineering Requirements of IEC 62366-1:2015, 2: 2016 - Webinar (Recorded)

  • Webinar

  • 90 Minutes
  • July 2019
  • Compliance Online
  • ID: 4899742
Why Should You Attend:

The International Electrotechnical Commission has recently published this updated standard, in two parts. It addresses an on-going concern by regulatory agencies in both the US and EU - human factors engineering / usability engineering. Usability can be defined as “the ability for a human to interact easily and relatively error-free with a system, product or procedure.” The FDA views human factors engineering as mandated to reduce user error and make medical products use as close to intuitive as possible. This webinar provides major benefits to company and user, such as:

Specific beneficial outcomes of applying human factors/usability engineering to medical devices include:

Easier-to-use devices
Safer connections between device components and accessories (e.g., power cords, leads, tubing, cartridges)
Easier-to-read controls and displays
Better user understanding of the device's status and operation
Better user understanding of a patient's current medical condition
More effective alarm signals
Easier device maintenance and repair
Reduced user reliance on user manuals
Reduced need for user training and retraining
Reduced risk of use error
Reduced risk of adverse events, and
Reduced risk of product recalls

Employment of these principles is carefully looked for and reviewed by regulatory agencies in device submissions, especially as products and procedures become ever more complex.

Areas Covered in the Webinar:

Key parts of IEC 62366-1
Written for easier to understand intent / implementation
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
Defined engineering process
User interface considerations


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 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 writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.