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
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
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
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
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
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
X-os, Genève Suisse
- CE marking support for a bone extension implant and ISO 13485 certification for the company
- Mission as outsourced quality manager
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
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
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.
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