Founded in 2005, BIOSYNEX has established itself as a leading French manufacturer specializing in the design of rapid diagnostic tests. Its innovative solutions are now distributed in Europe and in over 90 countries, playing a key role in improving overall patient care. With the aim of offering a range of “Made in Europe” medical devices, BIOSYNEX CHOSE TO RELOCATE THE ASSEMBLY OF FINISHED PRODUCTS, INCLUDING THE MANUFACTURE OF ELECTRONIC BOARDS (PCBA), TO CORDON GROUP’S FACILITIES IN FRANCE.
It’s much easier to have the manufacturers nearby. We can meet with them, talk face-to-face, and have much better visibility on lead times. Everything moves faster compared to sourcing from the other side of the world. Not to mention, the quality here in France is far superior to what we find elsewhere.
- Managing Director, BIOSYNEX Group
Our EMS site in France, ISO 13485 CERTIFIED, stands as a guarantee of reliability and ensures full compliance of the medical device with current regulations. From the very first stages of the project, we worked in close synergy with BIOSYNEX to anticipate industrial constraints and optimize the entire manufacturing process (DFM). Based on BIOSYNEX’s specifications, our teams ensured the PERFECT ALIGNMENT BETWEEN PRODUCT DESIGN AND REGULATORY AND OPERATIONAL REQUIREMENTS OF THE MEDICAL SECTOR.
Our solution includes full traceability of every step and every component, supported by systematic and documented quality checks to guarantee the reliability of the biomedical device. As experts in electronic component sourcing and customs procedures, our teams secure and streamline the management of all supply chain flows. To answer financial risks and environmental challenges, we anticipate supply and obsolescence issues and support BIOSYNEX in identifying the right strategies.
Each blood pressure monitor is manufactured in a controlled environment, with thorough documentation of every step of the manufacturing and integration process, ensuring COMPLETE TRANSPARENCY for BIOSYNEX. Cordon Group has developed a CUSTOM TEST SOLUTION specifically for these devices. It enables systematic testing of each unit before market release, ensuring the highest levels of quality and reliability, all under the real-time supervision of our client.
Cordon Group reinforces its commitment to the healthcare sector by delivering fully compliant solutions (EUropean Medical Devices Regulation and ISO 13485) : manufacturing and assembly, logistics, installation, maintenance, customer service, repair, refurbishment, and recycling.
