This course is designed to provide participants with an understanding of the impact that ISO 14971:2007 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971:2007 can improve their business and risk management efforts. Participants will also understand how ISO 14971:2007 applies to ISO 13485:2003.
The training includes exercises, and participants will have the chance to ask questions about how ISO 14971:2007 and risk management apply to their organizations. Particular focus is on the changes to the 2007 version and how the changes impact the risk management process.

Learning Objectives:

Upon completion of this course, participants will be able to:

• Describe the role of risk management in the medical device industry
• Explain the application of ISO 14971:2007 to ISO 13485:2003 in different markets worldwide, including GHTF guidance. 
• Explain the importance of management involvement with ISO 14971:2007 implementation and its impact on all parts of the organization 
• Identify recent changes and how they impact the organization 
• Demonstrate the basics of risk management using some of the tools and techniques of ISO 14971

Who Should Attend:

The intended audience for this course includes:

• Regulatory, quality, design (including design changes), development, manufacturing, marketing managers and personnel
• Decision makers on management system strategy
• Internal auditors

Prerequisite:

Participants should have experience with or basic knowledge of quality management systems for the medical device industry. Recommended is a basic awareness of medical devices, quality assurance, and ISO 13485:2003.

This course can be delivered as in-company training, customized for specific organizations and their circumstances.