Qualification of 3D additive printing and begin of manufacturing of first tasks
Eragny-sur-Oise, Fleurieux sur l’Arbresle, France, September 22th, 2022 –Protected Medical , a subsidiary of Protected Group (FR0013467123 – ALSAF), an organization specializing within the design, manufacturing and advertising and marketing of single-use applied sciences for spinal surgical procedures, delivering the most secure remedy for spinal fractures urgently handled, publicizes the renewal of its iso 13485 certification for its industrial manufacturing web site in Fleurieux sur l’Arbresle.
Protected medical, a subsidiary that manufactures medical units for Protected Orthopaedics and for third events, has had its ISO 13485 certification referring to high quality administration requirements to supply medical units renewed for the following three years.
As well as, one yr after the commissioning of the positioning’s clear rooms, the Protected Group has introduced the whole internalization of the manufacture and packaging of its ready-to-use surgical kits.
Lastly, the qualification of 3D steel additive printing, financed by the stimulus plan in 2021, signifies that the primary tasks for new-generation medical units can now be put into manufacturing, offering shapes and buildings that facilitate bone regrowth, significantly within the case of interbody cages.
“For the reason that summer time of 2020, our Protected Group has been engaged in a manufacturing integration course of. Manufacturing and innovation in ready-to-use applied sciences require particular industrial sources and abilities that Protected Medical has applied and certified over the previous two years. We’re very proud to announce the renewal of our ISO 13485 certification in addition to the enlargement of our industrial capabilities with the qualification of additive printing,” commented Pierre Dumouchel, Chairman and CEO of the Protected Group. “We at the moment are producing all of our Protected Orthopaedics applied sciences in-house, halving our manufacturing lead instances and enhancing our gross margin and related working capital. These new amenities additionally allow us to supply different Protected Medical clients a really wide selection of business processes, facilitating the qualification of processes which might be more and more constrained by new European regulatory necessities, in addition to financial savings in contrast with a multi-supplier provide chain. Our double-digit development confirms this group technique “.
About Protected Group Protected Group is a French medical expertise group that brings collectively Protected Orthopaedics, a pioneer in ready-to-use applied sciences for spine pathologies, and Protected Medical (previously LCI Medical), a medical gadget subcontractor for orthopaedic surgical procedure. The group employs roughly 150 folks.
Protected Orthopaedics develops and manufactures kits combining sterile implants and single-use devices, accessible at any time to the surgeon. These applied sciences are a part of a minimally invasive method geared toward lowering the dangers of contamination and an infection, within the curiosity of the affected person and with a optimistic affect on hospitalization instances and prices. Protected by 18 patent households, SteriSpineTM kits are CE marked and FDA authorized. Protected Orthopaedics is headquartered within the Paris area (95610 Eragny-sur-Oise) and has subsidiaries in the UK, Germany, the USA and the Lyon area (Fleurieux-sur-l’Arbresle).
For extra info: www.safeorthopaedics.com
Protected Medical produces implantable medical units and ready-to-use devices. It has an innovation middle and two manufacturing websites in France (Fleurieux-sur-l’Arbresle, 69210) and in Tunisia, providing quite a few industrial companies: design, industrialization, machining, ending and sterile packaging. Supported by the French stimulus plan in 2020, the corporate invests in additive printing and will likely be operational in 2022 on this new expertise.
For extra info: www.safemedical.fr
Contacts Protected Group François-Henri Reynaud Chief Monetary and Administrative Officer Tél. : +33 (0)1 34 21 50 00 firstname.lastname@example.org