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.
Program:
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
14:00-17:00
Risk Management ISO 14971:2019 interface
Usability Engineering ISO/IEC 62366-1:2015 interface
Post Market Surveillance MDR/IVDR interface
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).
Price:
5500SEK/person incl lunch, course material and certificate
Registration:
Information
- When: to
- Where: Medicon Village
- Organizer: Suturion
- Language: Swedish and English
- Price: 5500 VAT not included
Registration
Please register no later than Friday 3 November 2023
Contact information
- Anna Wikermark
- anna.wikermark@preventia.se