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The Value of a Human Factors Program
Date
Jan 14, 2021 - 10:00 AM
Link to Website
Organizer
Netzealous LLC DBA - Compliance4All
Venue
online
Location
161 Mission Falls Lane, Suite 216,,
Fremont,
California,
United States,
ZIP: 94539
Phone: 8004479407
Ticket Price: One Dial-in One Attendee Price: $150.00
Overview:
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2021 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: [email protected]
This webinar will explain the implementation of ISO 62366 and the regulatory expectations discussed in the 2021 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: [email protected]
Event Categories
Keywords: Educationa