Proper Documentation of Risk Management for Compliance with ISO 14971 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
recertification upon full completion.
Date & Time:
Tuesday, May 8, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Edwin L Bills
Price : $245.00
(for one participant)
Overview: There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard. However, most manufacturers are only using one tool, FMEA. The other tools are being ignored with a result that often does not meet the requirements of ISO 14971. This presentation will deliver a practical discussion on the proper use of the tools available to conduct product risk management and achieve a result that complies and also provides a more complete product risk analysis resulting in reduced cost and improved time to market with a lower risk product.
Areas Covered in the Session: l l l l l l
Exploring the Risk Management tool set Choosing the right risk management tools What tools are used during each phase of design? Meeting Human Factors regulatory requirements How to document standards compliance How to develop an FMEA that meets requirements.
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Edwin L Bills Principal Consultant, Bilanx Consulting LLC During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management. ...more
Who Will Benefit: l l l l l l l
Product Risk Management Design Engineers Human Factors Engineers Medical/Clinical Project Team members Project Managers
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Published on Apr 2, 2012
There are a wide variety of risk management tools cited in ISO 14971, the medical device risk management standard.