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More and more manufacturers are using artificial intelligence processes, especially machine learning (ML), in their medical products. However, there are currently no specific legal requirements for the use of these methods. In addition, the manufacturers and notified bodies lack harmonized standards. Therefore, both use the AI guidelines of the Johner Institute. In this seminar, the speaker conveys
- how existing regulatory requirements can be transferred to ML-based products,
- which standards and guidelines from other domains can be applied,
- which risks exist specifically when using ML methods,
- what options manufacturers have to manage these risks,
- what expectations notified bodies have of manufacturers (pre- and post-market),
- how manufacturers work with existing AI guides to demonstrate compliance.
The seminar consists of a presentation part and a part in which the speaker is available for questions and assistance in the development and approval of specific products.
topic overview
- Avoiding regulatory problems during audits
- Communicate with auditors and examiners on an equal footing
- Minimize product approval issues
- Reducing effort and costs in data collection and development
target group
This seminar is aimed at developers, data scientists, regulatory affairs and quality managers as well as clinical affairs managers.
previous knowledge
Not required, except knowledge of machine learning techniques in technical discussions.
KONTAKT:
Online
