Usability/Human Factors Engineering—The New IEC 62366-1, and -2 Standard, and EU / FDA Expectations

Event Information
6 Days
Left To Register
Product Format
Live Webinar
Presenter(s)
Conference Date
Add to my calendar   Tue, May 30, 2017
Aired Time
1 pm ET | 12 pm CT | 11 am MT | 10 am PT
Length
90 minutes
Product Description

Application of the New Usability Engineering Standard to Medical Devices in the US and EU

 

The IEC’s 2015 usability standard for new medical devices (IEC 62366-1:2015 Part 1) addresses the growing concerns of regulatory agencies in the US and EU about how easily a person can interact with a system, product or procedure.

Engineering for optimal human use is vital to the FDA, with the agency mandating in guidance documents that manufacturers make medical devices and products so that human error is reduced and the products can be used intuitively.

This webinar, by expert speaker John E. Lincoln, will address the requirements of the IEC standard, as well as the non-regulatory tutorial/guidance of its companion, “IEC/TR 62366-2:2 Part 2: Guidance on the application of usability engineering to medical devices”.

The webinar will answer basic questions device manufacturers, start-ups, investors and other stakeholders have as to the basic medical device development process incorporating Human Factors/Usability Engineering and its documentation/files, in the U.S. and EU. You will also get an overview of the basic activities and documents to show compliance to this new standard as expected by both the U.S. FDA and European Union, and other governing bodies.

Session Highlights

The session will provide an overview of:

  • Key parts of IEC 62366-1 and its implementation
  • Part 1,  “what”, and Part 2, “how”
  • Ties to ISO 14971, medical device risk management
  • Closer adherence to US FDA guidance;  more harmonization
  • Planning requirements
  • The 9-stage engineering process
  • User interface considerations
  • Scenarios, formative and summative evaluations
  • The usability engineering file

Who Should Attend

  • R&D
  • Engineering
  • QA/RA
  • Operations
  • Mid- and Senior-Level Management
  • CEOs and CFOs
  • Sales and Marketing
  • Purchasing
  • Other Medical Device Manufacturing Stakeholders

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

John E. Lincoln


John E. Lincoln is the 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...   More Info
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