World Conference Calendar

35118 Conferences

The Value of a Human Factors Program

Added by globalcompliancepanel on 2018-01-04

Conference Dates:

Start Date Start Date: 2018-02-22
Last Date Last Day: 2018-02-23
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2018-02-20

Conference Contact Info:

Contact Person Contact Person: Event manager
Email Email: john.robinson@globalcompliancepanel.com
Address Address: Four Points by Sheraton Los Angeles International Airport, Los Angeles, CA, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

This seminar 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 you should attend:
This year FDA published their priority list for the completion of their Guidance documentation. This FDA activity gives us inspection and enforcement insight into the priorities within the agency. Human Factors was in the #3.

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 Seminar will help to sort through the confusion of the FDA Guidance and ISO standards and help meet regulatory expectations by demystifying 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
Medical Device Manufacturing
Software Developers
Engineering Managers

Read More: http://www.globalcompliancepanel.com/con trol/globalseminars/~product_id=901501SE MINAR?worldconferencecalendar-February-2 018-SEO
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