Event starts on January 12, 2018 10:00 am
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  • Price
  • Ends January 12, 2018 11:00 am
  • Location Others
  • Category People & Health
  • Created November 21, 2017
  • Author Adam Fleming

Product Description

Overview:
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2016 FDA Guidance for a compliant human factors/ usability program.

Why should you Attend:
This year FDA published their priority list for the completion of their Guidance documentation. This annual activity gives us inspection and enforcement insight into the priorities within the agency. Interoperability and Cybersecurity were in the top 3. The implementation of a robust HF program will include both of these disciplines. Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. This webinar will help to sort through the confusion of the standard and help meet regulatory expectations by enumerating the tasks necessary to build a robust Risk based HF program.

Areas Covered in the Session:
HF Planning
Scope of Validation
Use Scenarios
Step by Step HF Program Development

Who Will Benefit:
QA/QC Personnel
Manufacturing
Software Developers
Engineering Managers

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Amenities

  • E-Ticket

Video

Contact

E-mail
support@compliance4All.com
Phone
18004479407
Website
http://www.compliance4all.com/control/w_product/~product_id=501638LIVE?channel=tixtore_Jan_2017_SEO
Address
Online

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