Safe Medical announces the renewal of the ISO 13485 certification of its production site in an extended scope that includes clean rooms

Safe Orthopedics

Safe Orthopedics

  • Certification renewal for 3 years

  • Completely in-house production

  • Additive 3D printing qualification and production of the first projects

Éragny-sur-Oise, Fleurieux sur l’Arbresle, France, September 22, 2022 5:45 PM – Safe Medical, a subsidiary of Safe (FR0013467123 – ALSAF), The group specializing in the design, manufacture and marketing of ready-to-use technologies for orthopedic surgery, in particular back surgery, announces the renewal of its ISO 13485 certification for its industrial production site in Fleurieux on the Treesle.

Safe Medical, a subsidiary of industrial production of medical devices for Safe Orthopedics and for third parties, has renewed its ISO 13485 certification regarding quality management standards for the production of medical devices for the next three years.

In addition, a year after the clean rooms of the enclosure were set up, the Safe group announces the total internalization of the manufacture and packaging of its ready-to-use surgical kits.

Finally, the qualification of additive 3D printing in metal, financed by the recovery plan in 2021, now makes it possible to start production of the first new-generation medical device projects, allowing shapes and structures to facilitate bone regrowth in the case of the intersomatics. particular cages.

“Since the summer of 2020, our Safe group has been in a process of productive integration. Manufacturing and innovation in off-the-shelf technologies require industrial resources and specific skills that Safe Medical has implemented and qualified over the last two years. We are very proud to announce the renewal of ISO 13485 certification as well as the expansion of our industrial capabilities with additive printing qualification. » comments Pierre Dumouchel, president and CEO of the Safe group “We now produce all of our Safe Orthopedics technologies in-house, cutting manufacturing times in half, improving our gross margin and associated working capital. These new facilities also make it possible to offer the rest of Safe Medical’s clients a very wide range of industrial processes, facilitating the qualification of processes that are increasingly conditioned by the new European regulatory requirements and savings compared to a multi-supplier supply chain. Our double-digit growth reinforces this group strategy”.

About Insurance Group
Safe Group is a French medical technology group that brings together Safe Orthopedics, a pioneer in turnkey technologies for spinal pathologies, and Safe Medical (formerly LCI Medical), a medical device subcontractor for orthopedic surgery. The group employs approximately 150 people.

Safe Orthopedics develops and manufactures kits that combine sterile implants and single-use instruments, available to the surgeon at any time. These technologies are part of a minimally invasive approach aimed at reducing the risks of contamination and infection, in the interest of the patient and with a positive impact on the duration and costs of hospitalization. Protected by 18 families of patents, SteriSpine kitsTM They are CE and FDA approved. Safe Orthopedics, whose headquarters are located in the Paris region
(95610 Eragny-sur-Oise) has subsidiaries in the United Kingdom, Germany, the United States and in the Lyon region (Fleurieux-sur-l’Arbresle).

For more information :

Safe Medical produces implantable medical devices and ready-to-use instruments. It has an innovation center and two production sites in France (Fleurieux-sur-l’Arbresle, 69210) and Tunisia, offering numerous industrial services: design, industrialization, machining, finishing and sterile packaging. Backed by the French recovery plan in 2020, the company invests in additive printing and will be operational in 2022 with this new technology.

For more information :


safe group

Francois-Henri Reynaud
Financial and Administrative Director
Such. : +33 (0)1 34 21 50 00

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