The Value of a Human Factors Program

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.

The ISO 62366 is an "Consensus"Standard, making it a gold standard for regulatory submissions. We will look at other reference points regarding HF, like AAMI/ANSI HE75:2009 and how HF Engineering include consideration of:

Device Users
Use Environments and User Interfaces
Preliminary Analyses
Exploratory HF/Usability Evaluations
Hazard Mitigation and Control
We will look at the implication of HFE through Design Controls in the QSR:

Design input -includes "needs of the user and patient"
Design validation - "devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis"[incl. use related risks]
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
Speaker Profile
Thomas Bento 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 link: https://www.traininng.com/webinar/-200874live?channel=theconferencealerts-May_2019_SEO
Contact Info
Traininng.com LLC
Email: [email protected]
Phone: US: (510) 962-8903
Phone: Zurich: +41 - 43 434 80 33
Website : https://www.traininng.com