This briefing is designed to provide executives with the information needed to successfully migrate to ISO 13485. In addition, we will introduce students to the Risk Management standard ISO 14971. Our instructors have extensive medical device manufacturing experience and hands on experience with the standard. Our instructional methods include presentations, in-class discussion, real life examples, and exercises.
Learning objectives
- Understand all clauses of ISO 13485
- Understand and apply principles of ISO 13485 Clause 5: Management Responsibility
- Recognize the role of management in implementing and maintaining ISO 13485
- Understand basics of ISO 14971 – The medical device risk management standard
- Explore the relationship of FDA-GMP’s with ISO 13485
Course materials
Students receive comprehensive course manuals with reference materials.
Who should attend
- Executives and senior management
- Cross functional team members implementing the standard
Prerequisite
Knowledge of medical device manufacturing.
