Design Control/Design and Development process course (Medical Device)
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.
09:00-14:00 (lunch at 12.00)
- The Design Control/Design and Development process 21CFR 820.30/ISO 13485:2016 §7.3
- Design input
- Design output
- Traceability matrix
- Design review
- Design verification
- Design validation
- Design transfer
- Design changes
- Design History File/Design and Development File
- How MDSAP can be of help
Risk Management ISO 14971:2019 interface
Usability Engineering ISO/IEC 62366-1:2015 interface
Post Market Surveillance MDR/IVDR interface
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.
Course material is in English.
Presentation in English or Swedish (depending on the participants).
5500SEK/person incl lunch, course material and certificate
- When: to
- Where: Medicon Village
- Organizer: Suturion
- Language: Swedish and English
- Price: 5500 VAT not included
Please register no later than Friday 3 November 2023
- Anna Wikermark