Regulatory Requirements for Medical Devices Based on Artificial Intelligence

Regulatory Requirements for Medical Devices Based on Artificial Intelligence

Artificial intelligence is rapidly transforming healthcare, yet in Europe, there are no standardized regulations for AI-based medical devices under the Medical Device Regulation. This gap necessitates independent compliance verification by medical device manufacturers. This paper addresses the regul...

Full description

Saved in:
Bibliographic Details
Main Authors: Nguyen My Duyen, Sohrabi Keywan, Gross Volker, Scholtes Michael, Seifert Oskar
Format: Article
Language:English
Published: De Gruyter 2024-12-01
Series:Current Directions in Biomedical Engineering
Subjects:
artificial intelligence
medical device
regulatory affairs
training concept
Online Access:https://doi.org/10.1515/cdbme-2024-2112
Tags: Add Tag
No Tags, Be the first to tag this record!

Similar Items

Similar Items