Pearsalls of Taunton, UK, has been awarded the EN46001 European quality standard, which ultimately will allow the company to put the CE mark on its medical devices.
Pearsalls' products include materials for surgical sutures and textile implants, which are being developed with the help of a grant from the UK's Department of Health. Formal clinical trials began early this year for a number of devices including an endovascular graft-stent, which allows an aneurysm to be treated using keyhole surgery, and textile implants for stabilizing the spine and shoulder.
The newly awarded ISO9001 and its medical device application EN46001 give Pearsalls the right to ..
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