BSI's "Understanding ISO 14971:2007" 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 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 eEgineers, 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.
