BSI’s Understanding ISO 14971:2007 course is designed to provide participants with an understanding of the impact that ISO 14971 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 can improve their business and risk management efforts. Participants will also understand how ISO 14971:2007 and ISO 14971:2001 apply to ISO 13485. The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 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
- Recognize the application of ISO 14971 to ISO 13485
- Understand the importance of management involvement with ISO 14971 implementation
- Understand the impact of ISO 14971 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
- 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.
