About Design Control/ Design and Development and its process interfaces
What will you learn:
You will get knowledge of the Design Control/Design and Development process in detail and how to use the interface to other processes in an effective way.
Program:
09:00-14:00The Design Control/Design and Development process 21CFR 820.30/ISO 13485:2016 §7.3
- Product realization planning
- Design input
- Design output
- Traceability matrix
- Design verification
- Design validation
- Design transfer
- Design changes
- Design History File/Design and Development File
- MDSAP audit technique
14:00-17:00
- Risk Management ISO 14971:2019 interface
- Usability Engineering ISO/IEC 62366-1:2015 interface
- Post Market Surveillance MDR/IVDR interface
- The processes interface flow chart
Course Leader:
Anette Sjögren, PREVENTIA AB
Anette is a member of the Swedish (TK355 – ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) committee and was also part of the international PMS task force.
Language:
Course material is in English.
Presentation in English or Swedish (depending on the participants).