Design Control for Medical Devices

The need to establish process descriptions and processes interrelations are mandatory within the ISO 13485 and also a goal for effective Quality Management Systems. Many processes are working close to each other and there are possibilities to use those interfaces and avoid creating too many documents and still fulfill the requirements.

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:

09:00-14:00
The 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).