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.CSS
- 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
- Understand the impact of ISO 13485:2003 implementation on medical device
- 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
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