The need for action by evaluators and decision makers in Europe to ensure safe use of medical software

Digital Health Solutions (DHS) approved under the Medical Device Directive (MDD) in the European Union may be used until May 27, 2025. The regulation provides appropriate requirements for the products but lack the evaluation by an external independent organization. For many DHS, the company can make...

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Bibliographic Details
Main Author: Mattias Kyhlstedt
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-11-01
Series:Frontiers in Medical Technology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fmedt.2022.1063622/full