Training ISO 13485 basics
This course will help you to understand what ISO 13485 (medical devices - quality management systems - requirements for regulatory purposes) means for your organization. The course consists of both a practical and theoretical part.
At the end of the course you will know the basics of ISO 13485. You will have the required basic knowledge to implement a quality management system in your organization.
|Who should attend:
The course is intended for employees which are responsible for implementing an ISO 13485 quality management system.
Subjects that are discussed during the course are.:
- What are the standards requirements? (basic knowledge of ISO9001 is required)
- Which regulatory requirements apply?
- What is the relation with the medical device directive (MDD93/42/EC)?
- Practical case studies