content
The later success of a medical device depends to a large extent on its safety, usability and efficiency being proven in the first stage of its development. The "Design Control" tool supports the 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 a constant "Design Change Control" the safety of the medical device, which is already CE marked, is guaranteed. In this seminar, the participants will learn what the term “design control” stands for. You will get an overview of its essential elements over the entire service life of a medical device, based on 21 CFR 820 (FDA) and DIN EN ISO 13485.
topic overview
- Basics / scope of design control
- Design control from the regulatory perspective of Europe (DIN EN ISO 13485) and America (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 (dealing with design changes)
- Design History File (DHF)
target group
The seminar is aimed at people involved in the development of medical devices, e.g. managing directors, employees in quality management, developers, project managers and/or regulatory affairs managers.
previous knowledge
Not mandatory.
KONTAKT:
Online
