BSI's "Understanding ISO 14971:2007" course is designed to provide participantswithan 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 and ISO 14971:2001 apply 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:

• Understand the role of risk management in the medical device industry
• Practice the basics of risk management
• Interpret the clauses of ISO 14971:2007
• Recognize the application of ISO 14971:2007 to ISO 13485:2003
• Understand the importance of management involvement with ISO 14971:2007 implementation
• Understand the impact of ISO 14971:2007 Implementation on medical device organizations
• Identify the recent changes and how they will impact an organization wishing to sell devices globally

Course Materials:

Students receive comprehensive course manuals with reference materials.

Who Should Attend:

• Quality managers or implementers within an organization seeking or maintaining registration to ISO 13485:2003
• Decision makers on management system strategy
• Design Engineers, Process Engineers and Manufacturing Engineers
• Internal Auditors
• Management Team

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.

Course Logistics:

Certificates of attendance are provided at the completion of the course. Student : Instructor Ratio - 20:1