Presented by: Liz Balmores and Megan McGuire

1. Design
Assurance
Engineering (DAE)
Defined
Two DAE members and their roles
in the medical device industry
Presented by:
Liz Balmores
Megan McGuire

2. 2 | MDT Confidential

3. 3 | MDT Confidential
Endovascular Therapies
http://www.patient.co.uk/diagram/Arteries-Of-The-Body.htm

4. 4 | MDT Confidential

5. 5 | MDT Confidential
Job Titles in the Medical Device Industry:
 Design Assurance Engineer
 Reliability Engineer
 Design Quality Engineer
 Product Quality Engineer
 Quality Engineer
 Quality Engineer – NPD

6. 6 | MDT Confidential

7. 7 | MDT Confidential
R&D Engineers
Process Development Engineers
Regulatory
Clinical
Marketing
Project Managers
Manufacturing Engineers
Design Assurance Engineers
Operators
Technicians
Equipment & Calibration
Complaints Group
Manufacturing Quality Engineers
Packaging

8. 8 | MDT Confidential

9. 9 | MDT Confidential
• Gage R&R Studies
• Design Freeze
• Design Verification
• Design Validation
• Biocompatibility
• Competitive Testing
• Shelf Life
TEST, TEST, TEST
21 CFR 820.30 Design Control Guidance for Medical Device Manufacturers

10. 10 | MDT Confidential
DATA ANALYSIS

11. 11 | MDT Confidential
Risk Management

12. 12 | MDT Confidential
Documentation

13. 13 | MDT Confidential

14. 14 | MDT Confidential
Why Test Methods?

15. 15 | MDT Confidential
What are we testing?

16. 16 | MDT Confidential
How Do We Test?

17. 17 | MDT Confidential
Repeatability
Reproducibility
Test Method Validation

18. 18 | MDT Confidential
Test Method Documentation

19. 19 | MDT Confidential
What my parents think I do
What my fiance thinks I do What I think I do
What my friends and sisters think I do
Design Assurance Engineer

20. 20 | MDT Confidential
What We Really Do:

21. 21 | MDT Confidential