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News

LNE/G-MED targets certification service at the orthopaedic sector

G-MED North America : 04 January, 2008  (New Product)
LNE/G-MED, a world leader of voluntary and statutory certification in the medical device sector, is focusing on developing the orthopaedic sector as one of its strategic targets.
International regulations now rely on the certification of the quality management system, as well as the complete review of the design dossier for devices falling in class III within the European regulation, such as recently reclassified hip, knee, and shoulder prostheses.

To be an expert in such a highly technical specialty, LNE/G-MED is taking advantage of the recognised expertise of the company’s testing laboratory headquarters, which has been involved in characterising orthopaedic implants since the late 1980s, when French regulation required mechanical and material characterisation to assess the quality of products.

LNE/G-MED also appeals to auditors with its orthopaedic experience in quality management and regulatory affairs. In addition, orthopaedic surgeons assist LNE/G-MED with the review of innovative device technical files for the assessment of their clinical evaluation section.

More than 10 percent of companies currently certified by LNE/G-MED operate in the orthopaedic field. These companies ranging from start-ups to international corporations are located in Europe and North America. They include both legal manufacturers and contract manufacturers covering all the different typologies:

- large joint implants (hip, knee, shoulder replacement or resurfacing)
- spinal implants for fusion or arthroplasty
- small joints (hand, wrist, elbow, foot or ankle)
- osteosynthesis
- biomaterials, including products of bovine or human origin
- surgical instruments, arthroscopes.
- ortheses/prostheses.

The development of LNE/G-MED certification services in the USA through the company’s Washington DC subsidiary, has supported companies located in the North American territory. The certification body has already served several US orthopaedic companies, from start-ups to well established corporations.

In November 2007, LNE/G-MED was chosen by NuVasive to certify the compliance of one of its most innovative and strategic products, currently under clinical investigation in the USA.

The San Diego-based company is a medical device company focused on the design, development, and marketing of products for the surgical treatment of spinal disorders. The company’s product range includes its minimally disruptive surgical technology ‘Maximum Access Surgery’ platform.
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