Regulatory Quality Specialist

Training Benefits will include:


1. Understanding International regulatory requirements for Medical Devices 

2. Preparing key staff for future QA RA leadership roles and for supporting existing managers

3. CE Marking processes and correspondance

4. Quality System and Product Certifications

5. Preparing management review

6. Design Control for Medical Devices

7. CAPA - controlling key compliance requirements

8. Risk management (ISO 14971)

9. Linking the audit systems to management review

10. Identifying and highlighting new regulatory requirements

11. GMP regulations

12. This course will incorporate 21 CFR Part 820 and ISO 13485 guidance for quality and regulatory personnel


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 and Regulatory in the medical device industry who are responsible for supporting or aspire to management roles.


Contact Details

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