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Current regulatory issues of AI in the field of medical technology

  • This paper describes current issues regarding regulatory requirements in medical devices with a focus on data-driven / AI based approaches. It shows that the EU Medical Device Regulation (MDR) sets high requirements to assess product performance based on systematically collected data, whereas the collection of data is difficult in the EU. Contrary, it demonstrates that the FDA is currently very active in supporting the development of software based systems in the US with dedicated regulatory programs. In particular, it pursues more dynamic approaches for releasing software devices. The overall situation favors developments in the US. Thus, the paper surveys a program to support local entities on adapting AI technologies.

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Metadaten
Author:Martin HaimerlORCiDGND
URL:https://arxiv.org/abs/1903.08495#
ISBN:978-3-9820756-0-0
Parent Title (English):Artificial Intelligence: From Research to Application: The Upper-Rhine Artificial Intelligence Symposium UR-AI 2019, March 13th, 2019, Offenburg, Germany
Publisher:Hochschule Karlsruhe - Technik und Wirtschaft
Place of publication:Karlsruhe
Document Type:Conference Proceeding
Identifier:Im Katalog der Hochschule Furtwangen ansehen
Language:English
Year of Completion:2019
Release Date:2019/04/25
Tag:Data-driven approaches; FDA; Medical device regulation; Regulatory requirements
First Page:31
Last Page:36
Open-Access-Status: Open Access 
Licence (German):License LogoUrheberrechtlich geschützt