Overview of the Medical Device Risk Management Standard-ISO 14971

This medical device risk management webinar will provide attendees an overview of ISO 14971requirements and practical tips for implementing an effective system for managing risk. It will also discuss differences between the world-wide international standard ISO 14971:2007 and the Europe-only version risk management standard EN ISO 14971:2012.

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