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The references of Isocèle Conseil

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METROVISION

Manufacturer
Ophthalmology & Vision
Compliance Quality
  • Clinical Data Analysis Report - 510(k) Filing
  • Implementation of a Quality System
  • Technical Specifications

EASY SURGERY

Manufacturer
Ophthalmology & Vision
Compliance
  • CE Marking of Reusable Surgical Instruments for Cataract Treatment

NEORIS

Manufacturer
Ophthalmology & Vision
Quality
  • ISO 13485 Quality Management System for Pigment Suspensions Used in Keratopigmentation

OCELLUS

Manufacturer
Ophthalmology & Vision
Compliance Outsourced Quality Manager +1 prestation
  • ISO 13485 QMS Review and CE Marking Technical File
  • Certification Renewal in October 2010
  • Outsourced Quality Manager since 2011

GLOBALS

Distributor
Orthopaedic Surgery & Implants
Quality
  • Implementation of the ISO 13485:2016 Quality Management System for a Spinal Implant Distributor

OCULAR SCIENCES SAS

Manufacturer
Ophthalmology & Vision
Audit Quality
  • Upgrade to ISO 9001:2000 and ISO 13485:2003 Quality Management Systems - GMED Certification
  • Monitoring and Auditing of Purchasing, Production, Quality, and Management Processes

EVEREST Medical

Manufacturer
Orthopaedic Surgery & Implants
Compliance
  • CE Marking for a Device to Assist in Hip Prosthesis Implantation

OPHTIMALIA

Manufacturer
Ophthalmology & Vision
Compliance
  • Technical Documentation for CE Marking of a Device for Monitoring Eye Dimensional Changes Related to IOP

ENSTA

Manufacturer
Orthopaedic Surgery & Implants
Compliance
  • Regulatory Strategy for a Distractor (Osteogenic Distraction)

PRECILENS

Manufacturer
Ophthalmology & Vision
Outsourced Quality Manager PRRC +2 services
  • Monitoring compliance with the ISO 9001 and ISO 13485 Quality Management Systems as an Outsourced Quality Manager
  • Internal Audit Training

BODYFEED

Manufacturer
Orthopaedic Surgery & Implants
Compliance
  • Technical File for CE Marking of an Intervertebral Decompression Table

IMAGINE EYES

Manufacturer
Ophthalmology & Vision
Audit Compliance +1 prestation
  • Implementation of the ISO 13485 Quality Management System - CE Marking (TÜV, May 2005)
  • Internal Quality System Audits