index -Sterile Chain accreditation

Contract medical manufacturer Arrow Medical Ltd has completed the final stages of validation to extend the existing BSEN ISO 13485:2003 accreditation, to cover all manufacturing processes right up to full delivery of finished medical device products to the sterile supply chain.

This latest accreditation, confirmed following the commissioning of Arrow Medical's second clean room assembly facility at Kington Herefordshire, covers all clean room manufacturing processes. This includes related bonding and gluing processes, silicone injection, compression moulding, and radio frequency welding, as well as product assembly, packing and associated logistics.

Arrow Medical provides contract manufacturing services for a variety of medical devices, including laryngeal masks, assisted venous circulation systems, hysto and laparoscopy tubing sets, and other devices used in cardiology, orthopaedics and ENT surgery. Arrow also has the capability to manufacture products that include combinations of optics and precision engineered metal and polymer components.

This latest BSEN ISO 13485:2003 extended accreditations adds to Arrow Medical's existing certifications, which includes ISO 9001:2000, as well as FDA GMP.

ends

More about Medical Innovations Forum, Olympia, June 13th 2007

Go to http://www.medical-innovation.net/

5195/0607 Page updated 04 April 2010

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