Overview of the Medical Device Risk Management Standard-ISO 14971

Why Should You Attend:

This webinar will review the ISO 14971 standard and will explore the process for risk management. The requirements of the standard will be discussed, along with the valuable information for implementation developed for the annexes. It will also discuss some of the requirements that have important implications for the medical device manufacturer as they develop their implementation of the risk management standard. A guidance from the medical device risk management technical committee, ISO TR 24971, provides much useful information on implementation of ISO 14971, including the use of product and process standards. Differences between the world-wide international standard and the Europe-only version will be briefly discussed.

The presenter is a current member of the US national committee on medical device risk management. He was Co-chair of the AAMI committee, QM/WG04, on application of risk management to medical device and participated in the development of ISO 14971 risk management standard for medical devices.

Areas Covered in the Webinar:

• Risk Management process
• Requirements of the standard
• Interpreting the requirements
• Informative Annexes
• The use of ISO TR 24971 in implementation of risk management
• How ISO 14971 interfaces with other standards
• ISO 14971:2007 vs. EN ISO 14971:2012

Who Will Benefit:

• Product Risk Managers
• Quality Engineers
• Regulatory Affairs Personnel
• Design Engineers
• Process Engineers
• Design Managers
• Company Management

Instructor Profile:

During his 26 year career in medical devices, Edwin 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 Master’s 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 the international technical committee. 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 ELB Consulting in the area of medical device quality, regulatory, product liability and risk management.

Topic Background:

The International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) developed a joint standard for medical device risk management. This standard has formed the foundation for many other medical device standards, an international pharmaceutical guidance document and even an ISO general risk management standard. The process developed for ISO 14971 is now recognized as the risk management process to be followed by these other documents. While ISO 14971 focuses on medical device product safety, the techniques have wide application. The use of ISO 14971 in product safety applications for medical devices aids in meeting regulatory requirements, assists in producing safer products, and can help reduce costs of design and product liability. Meanwhile, the release of a Europe-only version of the risk management standard, EN ISO 14971:2012 has confused the industry over the requirements for medical device risk management.

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