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.

"This is a significant milestone for us," says Arrow Medical managing director John Johnson. "Arrow Medical can now fulfil all the process requirements, right from product development and raw material traceability to finished sterile products, ready for use in operating theatres and other clinical situations where sterile delivery is mandatory."

Arrow Medical quality co-ordinator Jo Privett commented, "Naturally, working towards this quality and performance standard was a major challenge, following on the heels of our substantial recent investments in silicone moulding and extended clean room capacity. However, because of the continuing demands of our customer base, we already had systems and processes operating well above the minimal BSEN 13485:2003 requirements. This obviously made the process training and implementation exercise easier, but we still had to work hard to ensure compliance with the critical demands of the sterile supply chain."

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

See Arrow Medical at the Medical Innovations Forum, Olympia, June 13th 2007

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

Contact John Johnson for more information on +44 (0) 1544 231760 or by email at john@arrowmedical.co.uk

Meet Arrow Medical at the Medical Innovations Forum 13 June go to http://www.medical-innovation.net/

5195/0607 Page updated 01 Jun 2007