Proper Documentation of Risk Management for Compliance with ISO 14971

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     Proper Documentation of Risk Management for Compliance with ISO

     Course "Proper Documentation of Risk Management for
     Compliance with ISO 14971" has been pre-approved by RAPS
     as eligible for up to 1.5 credits towards a participant's RAC
                                                                                             Register Now                         

     recertification upon full completion.

    Date & Time:                                                                       Instructor Profile:

     Tuesday, May 8, 2012               10:00 AM PDT | 01:00 PM EDT
                                                                                                      Edwin L Bills
     Duration: 90 Minutes               Instructor: Edwin L Bills                              Principal Consultant, Bilanx
                                                                                                      Consulting LLC
     Location: Online                   Price : $245.00   (for one participant)

                                                                                       During his 20 year career in medical
                                                                                       devices, Mr. Bills has held a number
    Overview:                                                                          of quality and regulatory affairs
    There are a wide variety of risk management tools cited in ISO                     positions. Mr. Bills is ASQ Certified
    14971, the medical device risk management standard.                                as Quality Engineer, Quality Auditor,
                                                                                       and as Manager of Quality/
                                                                                       Organizational Improvement. He
    However, most manufacturers are only using one tool, FMEA. The
                                                                                       also holds a certificate as Regulatory
    other tools are being ignored with a result that often does not meet
                                                                                       Affairs Certified through the
    the requirements of ISO 14971. This presentation will deliver a                    Regulatory Affairs Professionals
    practical discussion on the proper use of the tools available to                   Society, and a BS and Masters
    conduct product risk management and achieve a result that complies                 degree from the University of
    and also provides a more complete product risk analysis resulting in               Cincinnati. Recently, Mr. Bills served
    reduced cost and improved time to market with a lower risk product.                as US Industry Co-chair of the
                                                                                       Association for Advancement of
                                                                                       Medical Instrumentation committee,
    Areas Covered in the Session:                                                      QM/WG04, on application of risk
                                                                                       management to medical devices and
                                                                                       is a current member of this group.
       l   Exploring the Risk Management tool set
                                                                                       Mr. Bills has presented at training
       l   Choosing the right risk management tools                                    courses for the American Association
       l   What tools are used during each phase of design?                            of Medical Instrumentation (AAMI) in
       l   Meeting Human Factors regulatory requirements                               the area of risk management and
       l   How to document standards compliance                                        quality systems. Currently, Mr. Bills
       l   How to develop an FMEA that meets requirements.                             is the Principal Consultant at Bilanx
                                                                                       Consulting LLC in the area of
                                                                                       medical device quality, regulatory,
    Click here to register for this webinar
                                                                                       product liability and risk
                                                                                       management. ...more
    Who Will Benefit:

       l   Product Risk Management                                                    Suggest a Topic       More Webinars
       l   Design Engineers
                                                                                        Your Necessity is our Priority
       l   Human Factors Engineers
       l   Medical/Clinical Project Team members
       l   Project Managers
       l   Process Engineers
       l   Quality Engineers

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

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Description: There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard.