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EUROPRISME

Distributor
Cardiology & Cardiovascular
Quality
  • ISO 13485 Quality Management System for a Distributor of Implantable Devices Used in Cardiothoracic Surgery

EDUCAT

Manufacturer
Cardiology & Cardiovascular
Compliance
  • Technical Documentation for CE Marking of a Software Application for Therapeutic Education in Cardiology

BIOTRONIK

Distributor
Cardiology & Cardiovascular
Quality
  • Implementation of ISO 9001:2015 and ISO 13485:2016 Quality Management Systems - Monitoring the Quality Management System

BASECAMP Vascular

Manufacturer
Cardiology & Cardiovascular
Audit
  • ISO 13485 Quality System Audit

WITH A BRAVE HEART

Distributor
Cardiology & Cardiovascular
Quality
  • Implementation of the EN ISO 13485:2016 Quality Management System for a Defibrillator Distributor

SIVIEW

Manufacturer
Ophthalmology & Vision
Audit Compliance +1 prestation
  • CE Marking and Implementation of the ISO 13485 Quality Management System
  • Follow-up Audits

LAO

Manufacturer
Ophthalmology & Vision
Compliance Outsourced Quality Manager +2 services
  • Implementation of the ISO 13485 Quality Management System and CE Marking
  • Certifications obtained in July 2007
  • HAS Reimbursement Application

CORNELIA Contact

Manufacturer
Ophthalmology & Vision
Compliance Outsourced Quality Manager +1 prestation
  • Upgrade to ISO 9001:2000 and ISO 13485 Quality Management Systems
  • Certification through GMED
  • Responsable qualité externalisé

LABORATORY CONTACT SERVICES

Manufacturer
Ophthalmology & Vision
Outsourced Quality Manager Quality +1 prestation
  • Monitoring of the ISO 9001 and ISO 13485 Quality Management Systems
  • Regulatory Monitoring of Medical Devices
  • Outsourced Quality Manager Role

BENEDETTI

Manufacturer
Ophthalmology & Vision
Compliance
  • CE Marking Technical File for a Perforated Eye Patch for Eye Dressings

LUNEAU

Manufacturer
Ophthalmology & Vision
Compliance
  • Product Upgrade Assessment in Accordance with EN 60601-1 and EN 60601-1-2, 3rd Edition

2M CONTACT

Manufacturer
Ophthalmology & Vision
Compliance Outsourced Quality Manager +1 prestation
  • Upgrade of the ISO 9001 Quality Management System
  • CE Marking and ISO 13485 Certification (GMED, February 2003)
  • Responsable qualité externalisé