Understanding Medical Devices Design Controls
BSI's “Understanding Medical Devices Design Controls” course is
designed to provide participants with an understanding of the impact that ISO 13485:2003
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
13485:2003 can improve their business and design control efforts. The training includes
exercises, and participants will have the chance to ask questions about how ISO
13485:2003 for design controls and risk management apply to their organizations.
- Understand the role of design controls in the medical device industry
- Practice the basics of design controls
- Interpret the clauses of ISO 13485:2003
- Recognize the application of process and product validation concepts
- Understand the importance of management involvement with ISO 13485:2003 implementation
- Understand the impact of ISO 13485:2003 implementation on medical device organizations
- Identify the recent changes and how they will impact an organization wishing to sell devices globally
- Consider the life-cycle concept and how it applies to the design control process
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
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.
Certificates of attendance are provided at the completion of the course.
Student : Instructor Ratio - 20:1