by
Barbara Kram, Editor | November 30, 2009
Meeting Regulatory Scrutiny
The reprocessing and remanufacturing of medical devices is a widely adopted practice that is stringently regulated by FDA. Reprocessors must comply with, among other things, FDA's 510(k) and Quality System Regulation (QSR) requirements. For reprocessed devices that are subject to the 510(k) requirement, reprocessors must demonstrate that these devices are as safe and effective as original devices.
To this end, Ascent provides:
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-Only devices that meet FDA's 510(k) and QSR requirements
-Products that are substantially equivalent to new devices, with no evidence of added risk to patients.
-ISO 13485-2003 certification
A Trio of Stryker Acquisitions
As recently reported in DOTmed News, Kalamazoo, Mich.-based Stryker also picked up OtisMed, a company that makes software to help surgeons determine how best to fit total knee replacements. Stryker also purchased global rights to build and sell Sonopet's Ultrasonic Aspirators, tools used to pulverize and remove tumorous tissue. Stryker hopes its agreement with Mutoh Co., Ltd., a Japanese business that manufactures the device, and Synergetics USA, Inc., the U.S. sellers, will go into effect before the end of the year.
Read additional coverage in DOTmed News:
Stryker to Acquire Ascent Healthcare Solutions
https://www.dotmed.com/news/story/10859/
Stryker to Spend Almost $100 Million in New Acquisitions
https://www.dotmed.com/news/story/10769/
DOTmed Industry Sector Report: Disposables
DOTmed Business News
https://www.dotmed.com/news/story/8561/
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