Content
The subsequent success of a medical product depends largely on its safety, usability and efficiency being proven in the first stage of its development. The “Design Control” instrument supports development project management in keeping an eye on the entire life cycle of a medical product – from the initial idea to the end of marketing. With constant “Design Change Control” the safety of the medical device, which is already CE marked, is guaranteed.
In this seminar, participants will learn what the term “Design Control” stands for. You will receive an overview of its essential elements over the entire lifespan of a medical device, based on 21 CFR 820 (FDA) and DIN EN ISO 13485.
Topic overview
- Basics/Application of Design Control
- Design Control from the regulatory perspective of Europe (DIN EN ISO 13485) and USA (21 CFR 820)
- Design and development plan (development planning)
- Design input/output: from product requirement to product specification
- Integration of risk management according to ISO 14971 (risk analysis at product level)
- Design verification and validation
- Design review
- Design Transfer (DMR) and Design Change Management (handling design changes)
- Design History File (DHF)
target group
The seminar is aimed at people involved in the development of medical devices, e.g. B. Managing directors, quality management employees, developers, project managers and/or regulatory affairs managers.
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
