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Online Webinar 2019 - Live Webinar 60 minutes The Value of Human Factors



VenueOnine, USA - United States USA - United States



Topics/Call fo Papers

In recent history FDA and other regulatory bodies throughout the world have been publishing their guidance and policies around Human Factor Engineering and practices. This is the result of these agencies seeing industry not addressing this critical practice in the design and development of Medical devices. This paradigm shift gives us inspection and enforcement insight into the priorities of regulators.
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 and demystify the confusion of the standard and help meet regulatory expectations by enumerating the tasks necessary to build a robust Risk based HF program
Session Highlights
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 noted by FDA as a “Consensus” Standard, making it a gold standard for regulatory submissions and product integrity. 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:
21 CFR Part 820.30(c) Design input –includes “needs of the user and patient”
21 CFR Part 820.30(g) 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 ..”
Who will benefit
• QA/QC Personnel
• Manufacturing
• Software Developers
• Engineering Managers
Thomas Bento is a student of Quality and Regulatory Compliance and has been supporting the design, development and compliance of Medical Device Manufacturing for 17 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, Regulatory consulting and SVP at Nihon Kohden America. Now he is Consulting for Philips Medical Systems. Through his experience he has found that the common thread that runs through the fabric of most Medical Device Manufactures is that more is better in order to meet regulatory expectations. He finds that this is the exact opposite and that manufacturers are better off by cultivating a simplified defensible approach to regulatory compliance founded on understanding and addressing Risk Management Appropriately.

Last modified: 2019-10-09 20:57:35