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:
Scope of Validation
Step by Step HF Program Development
Who Will Benefit: