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    Live event Human Factors Engineering

    View: 318

    Website https://compliance2go.com/product/?pid=CP2014-431 | Want to Edit it 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

    DESCRIPTION

    Usability 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 In addition, FDA-CDRH has a draft guidance that explains their approach, which aligns with IEC 62366.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 Canada

    The flow of requirements starting from the initial documentation to usability validation

    The links between the Risk Management standard (ISO 14971:2007) and usability engineering

    The contents of the Usability Engineering file

    The FDA-CDRH draft guidance on usability engineering

    The flow of information and the parallels to IEC 62366:2007

    Who Will Benefit:

    Quality Managers

    Regulatory Affairs Managers

    Design Engineering Managers

    Design Engineers

    Complaint and Reporting Specialists

    Webinar Includes:

    Q/A Session with the Expert to ask your question

    PDF print only copy of PowerPoint slides

    90 Minutes Live Presentation

    Certificate of Attendance


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.