Device Design - Begin with the end in mind

Training Benefits will include:


1. Developing design sytems to comply with FDA QSRs and ISO 13485

2. Design Team Coordination

3. Preparing for 510k approval

4. Aligning systems for CE marking

5. Managing design changes

6. Minimising Time to Market

7. Prepare for design history file inspection

8. The Design Review

9. Design Verification and Validation

10. Role of the Independent Reviewer

11. Transfer to Manufacturing

12. Sustaining Systems


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, Design, Regulatory, Engineering, Operations and Sub Contractors to the medical device industry who are responsible for managing, implementing and using Medical Device Design Systems.


Contact Details

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