6/28/2010
Alquest CEO Linda Alexander speaks on increasing FDA requirements
in BusinessWeek article.
http://www.businessweek.com/news/2010-06-23/cytori-breast-repair-device-gets-higher-hurdle-at-fda.html
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5/24/2010
NAMSA Adds to Sterilization Validation Offering - STERRAD STerilization Services Now Available
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5/19/2010
CeeTox acquires assets formerly owned by ADMETRx, Inc.
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5/13/2010
Kinetic-Turbidimetric Method Added to In Vitro Offering
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3/29/2010
Contract test laboratories adjust to requests for more device testing, details from the FDA.
http://www.mpo-mag.com/articles/2010/03/put-to-the-test
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12/17/2009
NAMSA announced that it completed its acquisition of Alquest, Inc. based in Minneapolis. Alquest is a leading contract research organization (CRO) specializing in regulatory strategy, compliance and clinical trials management for the medical device industry.
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12/9/2009
NAMSA's Sterilization Monitoring Products department discontinues stocking code STNS-65.
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10/14/2009
NAMSA's Sterilization Monitoring Products department joins forces with Package Care in Sri Lanka and RS Micromedia International in Bangladesh.
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9/1/2009
NAMSA's Analytical Chemistry and Materials Characterization department doubles its capacity for medical device testing.
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7/15/2009
NAMSA’s Microbiology lab confirms that new athletic Crocs™ are sterile and safe.
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6/23/2009
NAMSA, a worldwide leader in the safety evaluation of medical devices, will start providing a certificate of conformance of the harmonized USP <381> and European Pharmacopeias without additional cost and time to our clients.
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6/1/2009
Northwood, Ohio - NAMSA, the world leader in the safety evaluation of medical devices, is now offering Custom Sterilization Indicating Labels with expanded capability to include label on label application.
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5/8/2009
As of April 2009, NAMSA will be implementing a change in our manufacturing process associated with our Radiation Chemical Process Indicators.
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5/1/2009
Beginning in April 2009, NAMSA Product Certification of Analysis and Certification of Conformance will be packaged with each individual order.
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8/25/2008
Through client feedback, NAMSA has identified a need to make a change associated with the packaging configuration of our Spore and Growth Promotion Suspensions. NAMSA will be implementing use of a new cap with attached septum.
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7/14/2008
Northwood, Ohio- NAMSA, the world leader in the safety evaluation of medical devices, introduces a new 2.5 ml volume configuration of our Growth Promotion Test Suspensions.
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3/27/2007
A Message from President and CEO, John Gorski
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1/5/2007
NAMSA’s Certification of Conformance (C of C) associated with our Chemical Process Indicators (CPI) for radiation processes were recently revised after the publication of the revised ISO 11140-1:2005. The verbiage related to radiation lass 1 CPIs had been revised to outline that a visible change in color to the indicator should be visible after exposure to 10 kGy dose levels.
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9/21/2006
Parsippany, NJ – September 21, 2006 - Applications in Intelligent Chromatics (AiC), a division of Sun Chemical, the world’s largest producer of printing inks and organic pigments, and NAMSA have announced a marketing agreement in which AiC will be the exclusive distributor of NAMSA’s Sterilization Indicating Inks.
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5/2/2006
Northwood, Ohio, May 2, 2006 - NAMSA, a leading contract research organization (CRO) specializing in the safety evaluation of medical devices, has begun construction of a new 10,000 square feet surgical suite and a 15,000 square feet addition to the toxicology facility in Northwood, Ohio.
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4/6/2006
Irvine, California, June 6, 2006 - NAMSA, a leading contract research organization (CRO) specializing in the safety evaluation of medical devices, has begun utilizing a new microbial identification system called the Vitek 2 Compact™. The turn around time associated with organism identification will be greatly reduced with use of the new equipment. Results can be generated in as few as 7 days compared to the typical 15 day period using other identification systems.
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9/1/2005
Northwood, Ohio, September 1, 2005 - NAMSA, the world leader in the preclinical testing of medical devices, moved its Georgia offices to an Atlanta address on August 26, 2005.
"Our move to the new facility was planned several months ago and it will be executed so there is very little or no disruption in service to our clients," said NAMSA CEO and President, Jeffrey Blair.
NAMSA Advisory Services, technical support and sales personnel will operate from the new offices located at:
900 Circle 75 Parkway
Suite 1240
Atlanta, GA 30339
770.563.1660
770.563.1661
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10/4/2004
Northwood, Ohio, October 4, 2004 - NAMSA, the world leader in the safety evaluation of medical devices announced plans to transfer testing that is currently performed in its Kennesaw, Georgia laboratory to NAMSA’s facility in Irvine California. The transfer of tests is not scheduled to begin until April, 2005.
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4/6/2004
Northwood, Ohio, April 6, 2004 – NAMSA now provides clients with a single source document that summarizes all of the testing performed at NAMSA for a specific device. An industry first, the NAMSA Certificate of Compliance can be used when submitting information to regulatory agencies, Notified Bodies or customers. The certificate serves as proof of compliance to applicable standards and will initially be available for ISO 10993 or FDA GP 95-1 required testing.
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8/25/2003
NAMSA, the world leader in nonclinical evaluations of medical devices and related products recently opened two facilities as part of its global expansion.
The first phase of biocompatibility laboratory expansion occurred at NAMSA Biomatech in Lyon, France. The second phase of global expansion is the new 45,000 sq, ft. animal facility and laboratory now operational in Northwood, Ohio in July of this year.
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2/19/2003
NORTHWOOD, Ohio, February 19, 2003 – NAMSA, the world leader in the non-clinical testing of medical devices, has recently acquired the Exakt® Histological Processing System for the testing and evaluation of implanted medical devices. The new system will first be implemented at NAMSA’s recently completed laboratory and world headquarters facility in Northwood, Ohio near Toledo but accessible to NAMSA clients worldwide.
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11/11/2002
NAMSA, one of the world’s largest independent testing laboratories has announced a partnership with SPS Medical Supply Corporation to distribute their complete line of sterility assurance products to several industrial market segments. These segments include medical device manufacturers, pharmaceutical companies, biotechnology firms, and contract sterilization laboratories. The agreement covers both domestic and international distribution. SPS Medical is the largest sterilizer-testing laboratory in North America with a commitment to being the lowest cost, “compliant” provider of sterility assurance products to both the acute and primary care markets.
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8/21/2002
NAMSA, the world leader in the nonclinical testing of medical devices, has begun construction of a new 52,500 square foot laboratory and administrative facility in Northwood, Ohio. The new facilities are scheduled for completion in April 2003 and will be located adjacent to the existing Northwood headquarters. The groundbreaking ceremony, held on May 3, 2002, was a part of NAMSA’s 35th anniversary celebration.
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7/17/2002
On July 1, 2002, NAMSA, the world leader in the nonclinical testing of medical devices, signed an agreement with Biomedical Research and Support Services Pte. Ltd. of Singapore, a medical technology company, to represent NAMSA’s testing services and products divisions
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6/3/2002
NAMSA, the world leader in nonclinical testing of medical devices, is preparing for the release of ISO 10993-18, “Chemical Characterization of Materials,” which was approved as a Draft International Standard (DIS) in March of 2002; these preparations include the expansion of NAMSA’s laboratory facilities, training seminars on medical device testing, and the distribution of the new Characterization MatrixTM publication for medical device manufacturers.
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2/1/2002
NAMSA, the world leader in the safety testing of medical devices, is celebrating its 35th anniversary in 2002 by expanding the laboratory and administrative facilities at its Ohio, USA, headquarters and continuing active participation in the world’s premier regulatory standards organizations.
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1/14/2002
NORTHWOOD, OHIO, JANUARY 14, 2002 - NAMSA, the world leader in nonclinical testing of medical devices, is implementing plans to prepare clients for the impact of the release of ISO 10993-18, "Chemical Characterization of Materials"; this standard will define in much greater detail the important characterization procedures required of device manufacturers in order to obtain approval of their devices by the U.S. Food and Drug Administration (FDA) and other regulatory bodies.
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12/1/2001
Northwood, Ohio, December 2001 – NAMSA Chemical Process Indicators show, at a glance, whether or not a product has gone through the sterilization process through the use of nontoxic inks that change color after exposure to gamma or e-beam radiation, ethylene oxide (EO), or steam. The self-adhesive, permanent labels are quick and easy to apply and are available in custom designs combining unique label dimensions with the NAMSA indicators.
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11/30/2001
On October 31, 2001, NAMSA acquired Cole Industrial Laboratories, LLC, of Toledo, Ohio, which manufactures the GroPro PLUSâ brand of growth promotion indicator organisms. Sean Colwell, founder and manager of Cole Labs, has accepted the position of National Accounts Manager – Products with NAMSA and will assist in the merger of the two companies’ growth promotion product lines, assets, and customer-related services.
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11/1/2000
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.
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10/1/2000
NAMSA Testing Services now offers the Local Lymph Node Assay (LLNA), a test model that uses both aqueous and DMSO extracts and provides quantitative results for sensitization testing of medical devices, while providing a turnaround time three to four weeks faster than traditional testing methods.
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9/1/2000
Biomatech, NAMSA’s French affiliate, now offers a full range of performance testing for medical device manufacturers who are interested in evaluating the efficacy of their products. Capabilities are available within the following areas: implantation (muscle, brain, intraocular, vascular, bone, and cartilage), including histopathological evaluation; anti-adhesion and wound healing studies; tissue and vascular grafts; corneal and ocular studies. A full array of laboratory animals is available for services offered. Technical advisors on staff (MDs, DVMs, pharmacists, and biologists) provide their combined expertise in designing and performing surgical studies.
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5/1/2000
NAMSA Testing Services now offers one-cell and two-cell mouse embryo tests to support the label claims made by manufacturers of reagents, supplies, or medical devices used in conjunction with assisted reproductive techniques (ART) and related procedures. The Food and Drug Administration has confirmed that all devices being submitted for clearance with label claims for use in ART (such as in vitro fertilization) must use the mouse embryo assay for lot-to-lot release, reinforcing the value of NAMSA’s new test.
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11/1/1999
The surgical facilities at the Ohio division were recently remodeled and expanded to cover a wider range of procedures. Countless capabilities are available within the following areas: implantation (muscle, cheek pouch, brain, IOL, vascular, stent, shunt); anti-adhesion and wound healing studies; bone implant and joint procedures; tissue and vascular grafts; urethral sphincter augmentation and prostate procedures.
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