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.
Personnel in Quality and Regulatory in the medical device industry who are responsible for supporting or aspire to management roles.
Incra Med Ltd.,
Unit 204 Business Innovation Centre,
NUI Galway,
Upper Newcastle,
Galway, Ireland.
Email: info@incramed.com
Phone: 087 2823571
(c) 2020 Incra Med Medical Device Solutions