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MATHYS Orthopedics SAS

Distributor
Orthopaedic Surgery & Implants
Quality
  • Implementation of ISO 9001 and ISO 13485 Quality Management Systems and Monitoring of the Quality System

CEA Saclay

Other
Medical Imaging & Radiology
Audit
  • Annual Internal Audit in Accordance with ISO 13485 and ISO 11137 - Laboratory of Applied Radiation (LABRA)

IMPLANCAST

Distributor
Orthopaedic Surgery & Implants
Audit Quality
  • Monitoring of the ISO 13485 Quality Management System for a Prosthetics Distributor
  • Internal Audit

IMPLANET

Manufacturer
Orthopaedic Surgery & Implants
Audit
  • Audit in accordance with ISO 13485, 21 CFR Part 820, and ANVISA for knee and spinal implants

AQUILAB

Manufacturer
Medical Imaging & Radiology
Compliance
  • Support for FDA Accreditation of Quality Control Software for Medical Imaging and Radiation Therapy

AG Medical

Distributor
Medical Imaging & Radiology
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking Documentation for Monitoring and Imaging of Patients Treated with Radionuclides

DENTAL EXPERT

Manufacturer
Dentistry & Dental Implants
Compliance European Representative
  • European Authorized Representative Services for Medical Masks
  • CE Marking Documentation for Regulation 2017/746

MODJAW

Manufacturer
Dentistry & Dental Implants
Compliance Quality
  • Implementation of the ISO 13485:2016 Quality Management System
  • CE Marking for Hardware/Software Solutions for Dental Surgery

LOAT

Manufacturer
Dentistry & Dental Implants
Compliance
  • Review and Compliance of the CE Marking Documentation for Class IIa Dental Alloys

AIREL

Manufacturer
Dentistry & Dental Implants
Quality Regulatory monitoring
  • Veille réglementaire
  • Support for the Transition to ISO 13485:2016 for a Manufacturer of Dental Chairs

PUL CONCEPT

Manufacturer
Dentistry & Dental Implants
Compliance Quality
  • Implementation of the ISO 13485 / MDSAP Quality Management System
  • MDR CE Marking for Mandibular Propulsion Device

CROWN CERAM Laboratory

Manufacturer
Dentistry & Dental Implants
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking for Dental Prosthetics