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SIMPORT

Manufacturer
In vitro diagnosis
Compliance Quality
  • Technical Documentation for CE Marking for Sale in Europe

MYXpression

Manufacturer
In vitro diagnosis
Quality
  • Implementation of the ISO 13485 Quality Management System for DMDIV

RD BIOTECH

Manufacturer
In vitro diagnosis
Compliance Quality
  • Support for CE marking of DMDIV (human diploid cells) for a genomic biotechnology company

PIXACARE

Manufacturer
Medical Software & AI (SaMD)
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for a Medical Image Sharing and Analysis Solution

METAFORA Biosystems

Manufacturer
In vitro diagnosis
Compliance Quality
  • Implementation of ISO 13485:2016
  • CE Marking of DMDIVs for Nutrient-Carrying Biomarkers

LSEE

Manufacturer
In vitro diagnosis
Compliance
  • CE Marking Technical File for a Connected Metabolic Tracker That Measures Lipolysis Biomarkers

OWKIN

Manufacturer
Medical Software & AI (SaMD)
Quality
  • Implementation of an ISO 9001 Quality Management System for the Development of AI Models and Machine Learning in Medical Research

NOVESIA

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

LUXIA Scientific

Manufacturer
In vitro diagnosis
Compliance
  • CE Marking for the DMDIV for Gut Microbiota Testing

LUMEDIX

Manufacturer
In vitro diagnosis
Compliance
  • Regulatory support for DMDIV based on luminescent nanoparticles

MY CYBERKINGDOM

Manufacturer
Medical Software & AI (SaMD)
Compliance
  • CE Marking for Software Designed to Train Cognitive Functions in a Virtual Environment

LLTECH

Manufacturer
In vitro diagnosis
Compliance
  • CE Marking for In Vitro Diagnostic Medical Device Software