The Value of a Human Factors Program

Fremont, CA
Human Factors Program, Development, Software Developers, Compliance Programs, Design validation, Hazard Mitigation, Medical Device Manufacturing

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
Software Developers
Engineering Managers

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407

Schedule of Presentations:

Friday, January 12, 2018
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