The Use and Mis-use of FMEA in Medical Device Risk Management

Why Should You Attend:

FMEA is a tool designed for product reliability, which has been modified for use in risk management but has some pitfalls in this use. The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process.

Areas Covered in the Webinar:

• How should I use FMEA in performing risk management?
• What are the problems with FMEA in risk management?
• How should detectability be used in FMEA?
• Is there a role for RPN (Risk Priority Number)?
• Are there other tools to use in conjunction with FMEA?
• Are there FMEA applications in production as well as design?

Who Will Benefit:

This webinar will inform personnel at medical device companies on how to properly use Failure Modes and Effects Analysis (FEMA) in performing risk management.

• Product design teams and personnel assigned to use FMEA at medical device companies
• Quality managers responsible for integrating risk management into quality systems
• Regulatory and compliance personnel who develop premarket filings and technical files for medical devices
• Personnel responsible for verification and validation activities
• Quality system auditors

Instructor Profile:

Edwin Bills, has over 30 years’ experience in the field of quality and regulatory affairs. During his career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions including a recent period as Corporate Director of Risk Management. Currently he consults and provides training in the area of medical device quality, regulatory and risk management.

Mr. Bills is also a member of the adjunct faculty serving Virginia Tech’s graduate on-line degree program in Health Products Risk Management. ASQ has awarded Mr. Bills with Fellow status as well as Certified Quality Engineer, Certified Quality Auditor, Certified Manager of Quality and Organizational Excellence, and he is a Regulatory Affairs Certified by the Regulatory Affairs Professionals Society.

Mr. Bills has also served in international standards work, participating in the development of ISO 14971 risk management standard and IEC 60601-1 electrical medical device standard. He also serves on the US national committee for the medical devices quality system standard, ISO 13485, which is currently being revised, and the international committee on medical device risk management.

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