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Microtest Announces Agreement to Operate Symmetry Medical Inc.’s PolyVac Sterilization Validation
Added: 08/15/2006
Type: Summary
Viewed: 838 time(s)
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Microtest Announces Agreement to Operate Symmetry Medical Inc.’s PolyVac Sterilization Validation

 Microtest (www.microtestlabs.com) has been selected to operate Symmetry Medical Inc.’s PolyVac facility new state-of-the-art Sterilization Validation Laboratory in Manchester, NH, Microtest President Steven Richter announced today.

Microtest will operate the facility and provide independent third party sterilization validation testing services for Symmetry Medical Inc. customers. Microtest is an ISO9001:2000 certified, FDA registered provider of microbiology and in-vitro toxicology laboratory services for the medical device industry.

Symmetry Medical Inc. became the first surgical instruments case manufacturer in the U.S. to offer complete services from manufacturing through validation.

Moreover, Symmetry Medical Inc.’s bold move is especially timely, according Richter.

“Many industry experts expect imminent action by the FDA guiding how, or even requiring, medical device manufacturers validate their sterilization recommendations,” Richter said.

“Symmetry Medical Inc.’s ability to consolidate the added step – perhaps soon to be requirement – of third-party validation into the case design and manufacturing process provides a significant time-to-market advantage to medical device manufacturers,” he added.

Richter said Microtest’s ability to provide the new laboratory service offering is based on the company’s industry-leading, 15 years of experience in providing sterilization validation testing and related services for its own clients.

The Symmetry Medical Inc. Manchester Design & Development Center (DDC) Validation Laboratory is open and in full operation.

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