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The references of Isocèle Conseil

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CEMENTIC

Manufacturer
Dentistry & Dental Implants
Compliance Quality
  • Implementation of the ISO 13485 QMS and 21 CFR Part 820
  • Support for CE Marking of Endodontic Dental Filling Cement

IST Cardiology

Distributor
Cardiology & Cardiovascular
Compliance Quality
  • Restoring Compliance with Regulatory and Standard Requirements
  • Implementation of an ISO 13485 Quality Management System

AXENTISS

Manufacturer
Dentistry & Dental Implants
Compliance Quality
  • Implementation of the ISO 13485 Quality Management System
  • CE Marking Support for Dental Implants and Ancillary Devices

InHEART

Manufacturer
Cardiology & Cardiovascular
Audit
  • ISO 13485 Quality System Audit

ANTHOGYR

Manufacturer
Dentistry & Dental Implants
Compliance Training course
  • Training on the New Medical Device Regulation - European Requirements and Clinical Data: MEDDEV 2.7/1 Rev4

IMPLICITY

Manufacturer
Cardiology & Cardiovascular
Audit
  • ISO 13485:2016 Internal Audit for Cardiac Telemonitoring Software

SURGYNAL

Distributor
Orthopaedic Surgery & Implants
Audit
  • ISO 13485:2016 Audit for a Distributor of Urogynecological Implants

HOLTER SUPPLIES

Manufacturer
Cardiology & Cardiovascular
Compliance
  • Updating the CE Marking in accordance with Regulation 2017/745 for portable home Holter monitors

SPARTHA

Manufacturer
Orthopaedic Surgery & Implants
Compliance
  • Regulatory Strategy
  • CE Marking for an Antimicrobial Coating and a Mandibular Propeller

TEKNIMED

Manufacturer
Orthopaedic Surgery & Implants
Audit Compliance
  • Class III Technical Dossier Audit in accordance with Regulation 2017/745
  • Quality System Audit

X-os

Manufacturer
Orthopaedic Surgery & Implants
Compliance European Representative +2 services
  • Implementation of ISO 13485
  • Support for CE Marking of a Bone Lengthening Implant and Orthopedic Instruments
  • Outsourced Quality Manager Role and European Authorized Representative Services

VOGINNOV

Manufacturer
Orthopaedic Surgery & Implants
Compliance
  • CE Marking of a Temporary Orthosis to Replace Plaster Casts for Lower Limb Immobilization