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FIRALIS

Manufacturer
In vitro diagnosis
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for a Biotechnology Company - DMDIV Biomarkers

DATEXIM

Manufacturer
In vitro diagnosis
Compliance Training course
  • Training on Regulation 2017/746 - Compliance Support for Cellular Diagnostic Imaging Software

EXOPHARM

Distributor
In vitro diagnosis
Compliance
  • Compliance with Regulation 2017/746 for DMDIV dispensers

CARCIDIAG

Manufacturer
In vitro diagnosis
Compliance
  • Support for CE marking of a DMDIV for the diagnosis of cancer aggressiveness

BIOPREDICTIVE

Manufacturer
In vitro diagnosis
Compliance
  • Support for CE Marking of a Software Platform for Non-Invasive Diagnostic Tests

French Blood Establishment, Brittany

Other
In vitro diagnosis
Compliance
  • Preparation of CE Marking Dossiers for In Vitro Diagnostic Medical Devices

BLISS DTX

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking under Regulation 2017/745 for Digital Therapy Software

DIAFIR

Manufacturer
In vitro diagnosis
Audit Quality
  • Audit and monitoring of the ISO 13485 quality management system for DMDIV for the detection of non-alcoholic steatohepatitis

BIONOBIS

Manufacturer
In vitro diagnosis
Compliance Quality
  • ISO 13485 Consulting
  • Support for CE Marking of an HLA Typing Kit

EPILAB

Manufacturer
In vitro diagnosis
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for a Tuberculosis Diagnostic Test

ANATOSCOPE

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking Technical File for Customized Anatomical Model Software

EMOSIS Diagnostics

Manufacturer
In vitro diagnosis
Compliance Training course
  • Audit Training
  • Review of CE Marking Technical Files for a Hemostasis Diagnostic Kit