Our references

Here are a few of our references. You can consult the entire list of our references here.

Logo de la société Dreem

DREEM, Paris (75)

  •   CE marking of a band measuring brain and body activity during the night.
  • Setting up of the requirements of the EN ISO 13485 standard v 2016 and the requirements of 21 CFR Part 820

SC MEDICA, Strasbourg (67)

  •   Implants for spinal surgery
  • CE marking of medical devices
  • Setting up of QMS ISO 13485: 2016
Logo de la société Carcidiag Biotech cancer glycosylation Expertise

CARCIDIAG, Guéret (23)

  •   IVD for diagnosing the aggressiveness of cancer
  • Support for CE marking
Logo de la société Fizimed

FIZIMED, Strasbourg (67)

  •  The EMY device is designed to improve the quality of life of women by offering a physical education solution for the perineal muscle
  • CE marking
Logo de la société Modjaw

MODJAW, Ste Hélène du Lac (73)

  •  Development, manufacturing (by sub-contracting) and sale of a material and software solution for dental surgery
  • CE marking
  • Setting up of ISO 13485 version 2016 quality system
Logo de VitaDX

VitaDx, Evry (91)

  •  Development of an in vitro diagnostic medical device in the field of cancer and infection diagnosis
  • Setting up of ISO 13485 and CE marking of IVD
  • Since 2018, mission as outsourced quality manager
Logo de la société Damae Médical

DAMAE Médical, Paris

  •  Development and marketing of a medical device to assist in the diagnosis of skin cancer
  • Support for clinical trials and CE marking
  • Since 2017, mission as outsourced quality manager
Logo de la société FDE

FDE, Saverne (67)

  •  Development of an ambulatory infusion pump
  • CE marking and implementation of the ISO 13485 quality system
Logo de la société Eden Innovations

EDEN Innovations, Eguilles (13)

  •  Access control devices and AED medical device (Smart Automated External Defibrillator)
  • Support for the implementation of an ISO 13485/ISO 9001 quality system and CE marking
  • Mission as outsourced quality manager
Logo de la société Tribvn

TRIBVN, Chatillon (92)

  •  Medical imaging in the field of in vitro diagnostics
  • Support for CE marking, FDA approval for the software solution and implementation of the ISO 13485 management system
  • Annual monitoring of the quality system
  • Regulatory monitoring service
Logo de la société Axilum Robotics

AXILUM ROBOTICS, Strasbourg (67)

  •  Support for the setting up of the ISO 13485 quality system and market release of a robot for TMS (Transcranial Magnetic Stimulation) treatment
  • CE, FDA and Canada regulatory requirements.
  • CE marking and ISO 13485 certification obtained in July 2013
  • Regulatory monitoring service
  • Followed since 2012
Logo Terpenetech

TERPENETECH (DubliN – Irlande)

  •  Designer of an anti-lice treatment
  • CE marking application and follow-up
Logo de la société Guichet

X-os, Genève Suisse

  •  CE marking support for a bone extension implant and ISO 13485 certification for the company
  • Mission as outsourced quality manager
Logo de la société LCS

LABORATOIRE CONTACT SERVICES, Caen (14)

  •  Contact lenses
  • Monitoring of the ISO 9001 and ISO 13485 quality management system
  • Regulatory monitoring of medical devices
  • Mission as outsourced quality manager
Logo du Laboratoire d'Appareillage Optique

LAO, Amphion les Bains (74)

  •  Scleral lenses and contact lenses
  • Setting up of an ISO 13485 quality management system
  • CE marking of medical devices
  • Certifications obtained in July 2007
  • Monitoring of the quality system as outsourced quality manager
  • HAS reimbursement file
Logo de la société Precilens

PRECILENS, Créteil (94)

  • Manufacturing of contact lenses
  • Monitoring of the ISO 9001 and ISO 13485 quality management system, regulatory requirements as Outsourced Quality Manager
  • Internal audit training
Logo de la société imagine eyes

Société IMAGINE EYES, Orsay (91)

  •  Design and manufacturing of Aberrometers, medical device for measuring ocular aberrations
  • Implementation of a quality management system, ISO 13485 standard
  • CE marking of the device. Certified in May 2005 with TUV.
  • Internal audits of the quality system.
Logo de la société Thermofina

THERMOFINA Dammarie Les Lys (77)

  •  Manufacturer and Distributor of medical devices
  • Compliance of the management system with ISO 9001 and ISO 13485 standardsCertifications obtained with the SGS at the start of September 2003
  • Follow-up of CE marking technical dossiers
  • Internal audits of the quality system

DIANOSIC, Malakoff (92)

  •  Polyurethane intranasal balloon catheter inflated with physiological serum designed to remain in place for 2-3 days to treat epistaxis
  • CE marking