Since its inception, IPSOGEN has always based its development on values centered on customer satisfaction:

• understanding their specific needs,
• commitment to bringing real added values,
• building strong confidence-based relationships with customers.

Offering products and services in the field of cancer diagnostic, puts IPSOGEN at the heart of an extremely demanding environment in terms of quality, transparency, security and monitoring of these services and products. To continue its growth centered on these values, IPSOGEN intends to maintain its ISO 13485 certification obtained in 2007 and has decided to broaden the scope of compliance of its Quality Management System, including now the U.S. requirements of 21 CFR part 820 entitled "Medical Device - Quality system regulation."

IPSOGEN’s Quality Management System is an essential part of the strategy of our company and I ask every collaborator to be involved in its implementation and improvement.

Vincent FERT,
President and CEO of IPSOGEN

In order to better control our activities, we have structured our operations into 3 main processes:

• Management process
• Achievement processes
• Support processes

A program of internal controls for all of these processes is performed with the objective to evaluate them and provide expected results and to make sure that the quality of our products and services is in accordance with the provisions. The results of these internal audits are used as input data for IPSOGEN quality reviews. These meetings are held every six months to control the effectiveness and relevance of the Quality Management System.

IPSOGEN’s quality system is also controlled by external regulatory bodies such as LNE /GMED,  the Agence Française de Sécurité Sanitaire des Produits de Santé in France, and the Food & Drug Administration in the USA.

IPSOGEN’s quality system, covering product design manufacturing and distribution, guarantees that the quality of a given product is maintained from its production to its delivery to the end-user.
The manufacturing process is made 100% in our certified ISO 13485: 2003 laboratories. Quality controls are made at all stages of production: from raw material reception to manufacturing, storage, packaging and shipping steps.