Overview :
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quantitative as is in device validation. Claiming success because e.g. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
Why Should You Attend :
Following the implementation of the results of Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required number of validation participants from each "distinct user population". We will explain 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. We will describe how to do this.
Areas Covered in this Webinar :
use error, hazard analysis, validation, use test planning, human factors validation, ISO62366, FDA Human Factors Guidance
Learning Objectives :
Learn how to conduct Human Factors validations that are FDA and ISO compliant
Who Will Benefit :
Engineering personnel,
QA,
Manufacturing management,
Management
For more information, please visit :
Email: support@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515
Level:
Intermediate
Speaker Profile :
Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices.
His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.
Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
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