Design Control & Risk Management University

Welcome to Design Control University! Over the next several months Procenius will be populating this website with the most detailed and insightful design control and risk management resources available online. Topics will range from a detail interpretation of design control regulation (21 CFR 820.30 and ISO 13485; ISO 14971:2007/2012) to the latest industry best practices and implementation techniques and commonly asked questions to meet all medical device development professional's needs.

1. Design Control Overview
2. Medical Device Classification
3. Design and Development Planning
4. Design Input and User Needs
5. Design Output
6. Design Reviews
7. Design Verification
8. Design Validation
9. Design Transfer
10. Design Changes
11. Design History File
12. Compliance to Design Control Regulation
13. Risk Management
14. Design Control Preamble
15. Design Control Guidance