Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List

Instructor: Robert A North
Product ID: 704551
  • Duration: 90 Min
This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2016

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

Why Should You Attend:

This webinar will discuss key differences in submission requirements between the FDA draft guidance on human factors, released in 2011, and the final guidance released on February 3, 2016, entitled Applying Human Factors and Usability Engineering to Medical Devices. An additional discussion in this webinar will focus on the FDA’s accompanying draft guidance regarding a list of high priority medical devices requiring human factors testing and, for non-listed devices, the conditions which may dictate that human factors data may be necessary for approval.

Areas Covered in the Webinar:

  • Understand the intent of the final guidance regarding pre-market human factors work expected by reviewers at CDRH
  • Know the key differences between the draft human factors guidance and the final guidance release
  • Understand the implications of the “priority device list” and requirements regarding human factors in pre-market submissions for devices not listed

Who Will Benefit:

  • Regulatory Affairs
  • Product Development Managers
  • Human Factors Engineers
  • Quality Engineering
  • Risk Management Teams

Instructor Profile:

Dr. Robert North is a regulatory-affairs focused human factors consultant specializing in the application of methods and analysis techniques for the management and control of medical device use related hazards, and usability measurement, particularly as applied to the FDA pre-market device approval process and international usability standards compliance. He has consulted with over 100 companies regarding the implementation and documentation of medical device usability and use safety. Dr. North is currently the faculty lead of the Association for the Advancement of Medical Instrumentation’s (AAMI) three day human factors course.

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Design Control Essentials for Medical Devices
FCPA, Anti-Bribery Act, and OECD compliance

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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