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With the 2018 launch of an extension intended to double our production capacities, we have acquired the ability to scale up our operations by equipping ourselves with an industrial resource offering the highest levels of performance.  

Performance at the highest level

The construction of a new building in the immediate vicinity of our head office has provided us with an industrial and logistical resource to match our ambitions. 

The operation covers 5,000 square metres, expanding our production areas, cold room storage areas and Cleanrooms (ISO7 and ISO8). All logistics and support functions are grouped together at a single location. This provides guaranteed long-term capacity at our facilities, while retaining the option of building further extensions on the same site. 

A centralized production cycle 

The Lille site has a cell culture workshop in which the monoclonal antibodies used in the manufacture of our reagents are produced, a formulation workshop (biology and chemistry) and automated distribution workshops for the distribution of the various formulated products in a series of formats intended for all types of use, whether manually or with automated systems: cans, bottles, microplates, etc. 

Automated blood grouping systems are prepared, configured and checked from start to finish at our premises.

At the heart of Europe’s largest campus

DIAGAST was the first company to set up an operation at the Parc Eurasanté in 1995. It is Europe’s largest university hospital campus, and is home to 3,400 staff on a 300-hectare site, in the immediate vicinity of the Lille CHU hospital research laboratories. Here, DIAGAST has found an environment perfectly suited to competition and innovation, at the heart of an exceptionally favourable ecosystem. 

Golden rule: safety and quality

The essential requirements of product safety and quality are the beginning and end of everything we do. Our solutions all meet the European and international regulations and standards in force in all countries where our devices are sold. They all comply with the IVDD quality management system specific to in vitro diagnostic medical devices.

Within DIAGAST, this extreme vigilance is an ever-present reality, shared by all of our staff in our pursuit of quality at every stage of our production cycles, from receipt of raw materials through to finished products. 

17% of staff in Quality & Regulatory
45% of countries in which our products are distributed require a specific registration process
46 licence approvals produced, covering 55 individual product types, obtained by DIAGAST under the FDA system.

DIAGAST’s milestones:

  • 1997: first ISO certification (9001) 
  • 2003: EC mark and ISO 13485 certification
  • 2008: first approval from the US Food and Drug Administration
  • 2012: certification of Good Manufacturing Practices by the Brazilian (ANVISA) and South Korean (MFDS) health agencies
  • 2018: MDSAP certification by GMED for Brazil, Canada and Australia
  • 2019: certification by GMED of the new industrial site for EC equipment.∙
  • 2020: FDA approval of the new industrial site for FDA equipment.