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
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
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
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
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
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
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