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MEDEX GUERBEY Group

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • Normative and Regulatory Review of New Medical Software Solutions

IMSTAR

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for DIV Cell Analysis and Diagnostic Support Software

MEDIFLOW

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • Regulatory Strategy for Logistics Optimization Software

MEDICAL EDUCATION CORPUS

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • Regulatory Review of a Software Application for Calculating Scores in Hepatology

GERI COMMUNICATION

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System

MAINCARE

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • CE Marking Technical Files for Medical Prescription Assistance Software

DERMAPOL

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • CE Marking for Skin Cancer Diagnosis Using Polarized Light Image Analysis

LUMIO

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • CE Marking for an AI Solution to Prevent Medication Errors in Hospitals

DATAMEDCARE

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the EN ISO 13485:2016 Quality Management System
  • Technical File for CE Marking under Regulation 2017/745 for the ADEL Santé Telemedicine Platform

INRIA

Other
Medical Software & AI (SaMD)
Compliance Training course
  • Training on Legal and Regulatory Requirements for Medical Devices
  • Tracking of CE and FDA Marking Files

CONTINUUM

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the EN ISO 13485:2016 Quality Management System
  • CE Marking Technical File for a Patient Tracking Solution

NODEA Medical

Manufacturer
Oncology
Compliance Quality +1 prestation
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking and Support for Clinical Investigations of a Device for Detecting Malignant Breast Tumors
  • Veille réglementaire