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Event Details


The Value of a Human Factors Program

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Who should attend?

QA/QC Personnel Manufacturing Software Developers Engineering Managers


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

Speaker Profile:
Thomas is a student of Quality and Regulatory Compliance and has
been supporting the design, development and compliance of Medical
Device Manufacturing for close to 15 years. He started his career
training in Software engineering and shortly moved into Commercial
Software Quality. After many years of working for companies like Mitek
Systems and Hewlett Packard, the decision was made to work in the
regulated space of Medical Device Manufacturing, working at Edwards,
Pulmonetic Systems and as a regulatory consultant for small, medium
and large Medical device manufactures. 

Event Fee: One Dial-in One Attendee Price: US$150.00

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


One Dial-in One Attendee Price: $150.00


Event Manager

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