Our references

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

SOMNO ENGINEERING, TOURS (37)

Analyzer and recorder for patients in intensive care and intensive care for sleep monitoring

  • Clinical investigation submission file
  • CE marking
  • ISO 13485 quality system

BLISS DTX LAVAL (53)

Digital therapy software

  • CE marking regulation 2017/745
  • ISO 13485 quality system
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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
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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
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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
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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
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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

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
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PRECILENS, Créteil (94)

  • Manufacturer of contact lenses
  • Monitoring of the ISO 9001 and ISO 13485 quality management system, regulatory requirements as Outsourced Quality Manager
  • Internal audit training

HYPNO VR, STRASBOURG (67)

  • Hypno VR is a product allowing to replace or complement the use of sedative in the context of surgical anesthesia through hypnosis using software and a virtual reality headset as technical means.
  • CE marking
  • Implementation of a Quality Management System according to the ISO 13485: 2016 standard

VEODIS IMPLANT, ST GEORGES LES BAILLARGEAUX (86)

  • Orthopedic implants
  • Implementation of an ISO 13485 version 2016 quality system

BIOTRONIK, RUNGIS, (94)

  • Commercial subsidiary in France of BIOTRONIK, manufacturer of implantable prostheses in cardiology
  • Implementation of quality system ISO 9001 version 2015 and ISO 13485 version 2016
  • Quality management system monitoring service

NOVAGRAY, MONTPELLIER (34)

  • CE marking and FDA registration of a DMDIV to measure the rate of lymphocyte apoptosis
  • Implementation of quality system ISO 13485 version 2016
  • Quality system monitoring

BIOPREDICTIVE, PARIS (75)

  • Provision via an Internet platform of non-invasive diagnostic tests, particularly for liver diseases.
  • Support for CE marking of a software platform for non-invasive in vitro diagnostic tests
  • Review of the technical file in 2019

IMPETO MEDICAL, PARIS (75)

  • Designer of a medical device for the diagnosis of diabetes.
  • Implementation of an ISO 13485 quality management system
  • CE marking of medical devices
  • ISO 13485 certification and CE marking obtained on July 16, 2009
  • File 510K
  • Followed since 2009

X-OS, GENÈVE SUISSE

  • Support for CE marking of a bone lengthening implant and ISO 13485 certification of the company
  • Mission of outsourced quality manager

AMIS, TRÉGUEUX (22)

  • Manufacturer of medical devices for endoscopy
  • CE marking technical files
  • Implementation of the EN ISO 13485: v2016 quality system

YLEA, LA VALETTE DU VAR (83)

  • Distributor of medical devices for care, known diagnostic devices (thermometers, blood pressure monitors, etc.), and consumables for hospitals
  • Implementation of the EN ISO 13485: v2016 quality system

METAFORA BIOSYSTEMS, EVRY (91)

  • Development of nutrient transporter biomarkers
  • Implementation of ISO 13485 version 2016 and CE marking of DMDIVs

CONTACT SÉCURITÉ, TOURS (37)

  • Medical device distributor
  • Compliance with regulation 2017/745
  • Quality system upgrade

IMPLANCAST, LYON (69)

  • Prosthesis distributors
  • Quality system monitoring

BRAINDEX, LILLE (59)

  • Medical device for optimizing anesthesia
  • CE marking regulation 2017/745