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The references of Isocèle Conseil

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AISCREENING

Manufacturer
Medical Software & AI (SaMD)
Quality
  • Quality System Monitoring for SaMD for the Diagnosis of Melanoma (AiSkin-Dt), Diabetic Retinopathy, and Glaucoma

DIAGANTE

Manufacturer
In vitro diagnosis
Compliance Quality
  • Regulatory Strategy - Technical File for CE Marking - Implementation of the EN ISO 13485:2016 Quality Management System
  • Implementation of the ISO 13485:2016 Quality Management System
  • CE Marking Technical File

BSMTI

Manufacturer
In vitro diagnosis
Compliance
  • Evaluation of Clinical Data from a Nephrostomy Set

BionextOne

Manufacturer
In vitro diagnosis
Compliance
  • Technical Dossier for Directive 98/79 on Software to Assist in the Triage of COVID-19 Patients

A2B ENERGY

Other
In vitro diagnosis
Compliance
  • CE Marking Declaration for COVID Tests

PRESTODIAG

Manufacturer
In vitro diagnosis
Compliance Quality
  • Support for the Implementation of the ISO 13485 Quality Management System
  • Support for CE Marking of Bacterial Detection Devices

VitaDx

Manufacturer
In vitro diagnosis
Compliance Outsourced Quality Manager +1 prestation
  • Implementation of ISO 13485
  • CE Marking for DMDIV Products
  • Outsourced Quality Manager since 2018

PATHOGENDX

Manufacturer
In vitro diagnosis
Compliance European Representative
  • DMDIV Technical Data Sheet
  • Role of European Representative

STILLA

Manufacturer
In vitro diagnosis
Compliance
  • CE Marking of a Genetic Analysis Device (Digital Droplet PCR) for Medical Research and Diagnosis

OASIS Diagnostics

Manufacturer
In vitro diagnosis
Compliance European Representative
  • DMDIV Technical Data Sheet
  • Role of European Representative

SPYDIAG

Manufacturer
In vitro diagnosis
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for DMDIV Urine Test Strips (BK Polyomavirus Diagnosis)

NOVAGRAY

Manufacturer
In vitro diagnosis
Compliance Quality
  • Implementation of the ISO 13485:2016 Quality Management System (QMS) - Quality System Monitoring
  • CE Marking and DMDIV Registration