Live event Human Factors Engineering
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Website https://compliance2go.com/product/?pid=CP2014-431 |
Edit Freely
Category Medical Device
Deadline: March 30, 2015 | Date: March 31, 2015
Venue/Country: Online, U.S.A
Updated: 2015-02-27 16:07:21 (GMT+9)
Call For Papers - CFP
DESCRIPTIONUsability Engineering, (Human Factors Engineering) is an essential part of a device development program. In fact, a major issue arises when a device works correctly, but is used incorrectly. This is called “use error” and can cause harm to a patient or user.If you have not implemented a Usability Engineering program, your design control system is not adequate. You open yourself up to audits, inspections, and product liability issues. The program will help you ensure your devices are used correctly and that ISO 14971:2007 risk reduction using information for safety is effective.The solution is to implement IEC 62366:2007 which explains how to create a Usability Engineering program. This international standard is recognised by FDA-CDRH and harmonized to the MDD. In addition, FDA-CDRH has a draft guidance that explains their approach, which aligns with IEC 62366.This webinar walks you through the Usability Engineering process and helps you implement an effective system that aligns with design validation including risk management.It also includes the recent amendment to the standard that covers User Interfaces of Unknown Provenance (UOUP). This approach will help you deal with legacy device issues.Areas Covered in the Session:The versions of IEC 62366 and its status in the US, EU, and CanadaThe flow of requirements starting from the initial documentation to usability validationThe links between the Risk Management standard (ISO 14971:2007) and usability engineeringThe contents of the Usability Engineering fileThe FDA-CDRH draft guidance on usability engineeringThe flow of information and the parallels to IEC 62366:2007Who Will Benefit:Quality ManagersRegulatory Affairs ManagersDesign Engineering ManagersDesign EngineersComplaint and Reporting SpecialistsWebinar Includes:Q/A Session with the Expert to ask your questionPDF print only copy of PowerPoint slides90 Minutes Live PresentationCertificate of Attendance
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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