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Conduct A Human Factors/ Usability Validation Test To Pass - ISO 62366

Faculty :

Industry :

Duration :

Course Description:

In this session we will explain
  • The procedure described in ISO 62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation test
  • Learn how human factors/ usability validation is very different from device validation
  • Define 62366 regulatory and/or design control deliverables
  • What criteria do you use to identify critical tasks from your risk assessment
  • We will also discuss documentation requirements
  • Also about if there is a timeline to comply with FDA human factors guidelines

For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Why should you Attend?

         When implementation of the results of a Human Factors/ Usability study are successful, human factors (HF) validation can be very straightforward. It is like checking off the boxes on a study protocol. But if all the pieces of implementation of the results of a Human Factors/ Usability study do not come together as planned, however, HF validation can be a complicated endeavor.

         In this webinar we will try and make it easy to have a straightforward implementation and explain the basic difficulties faces. Below would be a few of the questions this webinar will try to answer.

In the case of usability/human factors study, questions like:
  • Should risk and validation activities be covered separately
  • When should validation of the safety and effectiveness of the use of the device be conducted
  • For non-complex devices usability studies, what are sample size requirements
Also in brief discussion about the below:
  • What is the FDA required number of validation participants from each Distinct User Population
  • How to choose the tests to be conducted and the studies that must be completed prior to the actual validation test
  • The post test participant inquiry is critical to validation success

Areas Covered:

  • Required number of participants
  • Qualitative success criteria
  • choice of tasks to validate
  • Post test participant inquiry

Who will benefit?

This webcast will be of a valuable assistance to the below audience

  • Engineers
  • Engineering Management
  • Regulatory Personnel
  • QA/ QC personnel

Registration Options

Avail 12 months unlimited access for a single user.

Material shipped within 15 days post webinar completion & get life time access for unlimited participants.


ISO 62366, FDA Guidance, Validation Test, Human Factors, FDA, Medical Device, Device Validation, Risk and Validation Activities, Sample Size Requirements, Engineers, QA, QC

Speaker Details

Edwin Waldbusser

Edwin Waldbusser

Medical Device Consultant

Ed Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

Refund Policy

Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplyArena will issue a letter of credit to be used towards any of ComplyArena's future events. The letter of credit will be valid for 12 months.

ComplyArena will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: or call +1-888-222-5917 (Toll Free).