• Hydrogen Technologies Standards form the basic framework for market ramp-up

    More information
  • Climate change Standards and specifications support climate targets

    More information
  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

    More information
Project

Post-market surveillance of machine learning-enabled medical device

Abstract

This document extends the framework of post-market surveillance for medical devices with machine learning (MLMD) and describes specific requirements, metrics, methods, and procedures for implementation

Begin

2025-10-02

Planned document number

DIN IEC IEEE 63685

Project number

02233421

Responsible national committee

DKE/UK 811.3 - Sicherheit von medizinisch genutzten Geräten/Systemen/Einrichtungen in der vernetzten Anwendung  

Contact

Dorina Laurila-Epe

Merianstr. 28
63069 Offenbach am Main

Tel.: +49 69 6308-295

Send message to contact