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The references of Isocèle Conseil

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GRAFTYS

Manufacturer
Orthopaedic Surgery & Implants
Compliance Quality
  • Implementation of ISO 9001 and ISO 13485 Quality Management Systems
  • CE Marking

VEODIS Implant

Manufacturer
Orthopaedic Surgery & Implants
Quality
  • Implementation of the ISO 13485:2016 Quality Management System for Orthopedic Implants

SKELENN

Manufacturer
Orthopaedic Surgery & Implants
Compliance PRRC
  • CE Marking Technical File for Immobilization Splints
  • PCVRR Mission

SC MEDICA

Manufacturer
Orthopaedic Surgery & Implants
Compliance Quality
  • CE Marking of Medical Devices - Implementation of an ISO 13485:2016 QMS for Spinal Implants

United Orthopedic Corporation France

Distributor
Orthopaedic Surgery & Implants
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System and device registration for a subsidiary distributing implants in France

SATT Conectus Alsace

Other
Orthopaedic Surgery & Implants
Compliance Training course
  • Support for the SPARTHA project (innovative coatings for implants)
  • Quality and Regulatory Training for Medical Device Design

United Orthopedic Corporation Belgium

Distributor
Orthopaedic Surgery & Implants
Quality
  • Implementation of the ISO 13485 Quality Management System for a hip and knee implant distribution subsidiary in Belgium

IGT

Manufacturer
Medical Imaging & Radiology
Compliance Quality
  • Implementation of EN ISO 13485:2017
  • Support for CE Marking of an Imaging Device for Cancer Treatment

OCCISPHERE

Manufacturer
Orthopaedic Surgery & Implants
Compliance
  • Technical File for CE Marking under Regulation 2017/745 for Surgical Fields

GLEAMER

Manufacturer
Medical Imaging & Radiology
Compliance Quality
  • Implementation of EN ISO 13485:2016
  • CE Marking for Software That Improves Radiologists' Productivity

MEDACTA

Distributor
Orthopaedic Surgery & Implants
Quality Regulatory monitoring
  • Veille réglementaire
  • Update to Internal Procedures for the Hip, Knee, and Spine Prostheses Subsidiary

FIBERMETRIX

Manufacturer
Medical Imaging & Radiology
Compliance Quality
  • Implementation of the ISO 13485:2016 Quality Management System
  • CE Marking of a Scintillation Fiber Dosimetry Measurement System