11/1/2000
FOR IMMEDIATE RELEASE
NAMSA Expands Capabilities to Better Serve Worldwide Customers
Northwood, Ohio, November 1, 2000 – The French company Biomatech, a long-time affiliate of NAMSA located near Lyon, became NAMSA’s fourth medical device testing laboratory and base for European operations on November 1, 2000. This significantly expands NAMSA’s capabilities as the leader in the global medical device testing industry through the addition of functional and performance testing and clinical device testing. Founded in 1986, Biomatech has specialized in nonclinical safety testing for medical device manufacturers, providing an extensive array of services that complement those offered by NAMSA’s U.S. laboratories located in Ohio, Georgia, and California.
Biomatech’s services include functional and performance testing, biological models to determine product efficacy, and multicapability surgical procedures, in addition to biocompatibility and microbial testing. Biomatech also offers a comprehensive range of services in support of European clinical trials in compliance with EN540. Their clinical testing services include bibliography studies, retrospective and prospective studies, and clinical risk analysis and management.
“NAMSA’s international regulatory expertise and experience validating medical devices worldwide is significantly enhanced by the acquisition of Biomatech,” notes Judi Gorski, Vice President of International Operations. “Biomatech’s capabilities in such areas as functional and performance testing, histopathology and materiovigilance, in addition to clinical trials expertise, expand the scope of services that NAMSA will offer to manufacturers seeking certification for safety and performance of their medical devices. Also, our increased presence in France will be vital to better serving the European medical community.”
Jeff Blair, president of NAMSA, adds, “Dr. Rosy Eloy at Biomatech has done a superb job of building a significant, high-quality business. We are delighted our affiliation has grown to the point where we can truly feel the global synergy of our laboratories.”
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NAMSA is a multinational company with laboratories in the United States, France, and Taiwan, specializing in nonclinical testing services. NAMSA offers materials characterization, biocompatibility, and microbial testing to ensure the safety and efficacy of medical devices. The laboratories in Ohio, Georgia, and California have ISO 9001 certification. NAMSA also manufactures SPORTROLâ biological indicators, SPORTROLâ growth promotion products, chemical process indicators, and H-BACâ thromboresistant coatings.
For further information about Biomatech, contact:
Judi Gorski, Vice President of International Operations: judigorski@namsa.com
Or Biomatech/ A NAMSA Company
Zone Industrielle de I’Islon
115 Rue Pasteur
38670 Chasse-sur-Rhone, France
Phone (33) 4 78 07 92 34 FAX (33) 4 72 24 08 12
info@biomatech.fr
For further information about this press release, contact
Deborah Gibbs, NAMSA Corporate Marketing,dgibbs@namsa.com
Phone (949) 951-3110 ext. 204 FAX (949) 454-3059
