ISO 13485

Training Benefits will include:


1. What is ISO 13485 and why is it required?

2. How to implement ISO 13485 into the Quality System

3. Implementation of the standard - Organisation / People Considerations

4. Update from ISO 9001

5. Interanl Audits of ISO 13485 

6. The process-clause matrix

7. How to bring real business value from the standard

8. The Notified Body audit process

9. Responding to Notified Body observations

10. Integrating the audit process to Management Review

11. Integrating risk management

12. Practical auditing workshops


Every participant will have the opportunity to identify key requirements in advance of the course.

Free follow up consultation will be available post training from your course tutor. 

Who should attend?

Personnel in Quality, Engineering, Operations, Purchasing and Suppliers to the medical device industry who are responsible for managing, implementing and monitoring ISO13485 Quality systems or subsystems.


Contact Details

Incra Med LTD,
Unit 204 Business Innovation Centre,
NUI Galway,
Upper Newcastle,
Galway, Ireland.
Phone: 087 2823571