Netzealous LLC DBA - Compliance4All, Online
2018-01-12
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
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
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