ISO 9001:2000 certified since December 2002 under Certificate Number SG02/00296.
ISO 13485:2003 certified since November 2002 under Certificate Number B02/57664. The notified approval body is the SGS UK Ltd Yarsley International Services and approvals are UKAS accredited. The scope covers Product and Tooling Design, Moulding, Assembly, Packing and Sterilisation of Medical Devices. A surveillance audit is conducted every 6 months and a re-certification every 3 years.
Quality Management System (QMS) that complies with the requirements of ISO 9001:2000, ISO 13485:2003 and FDA CFR 21 Part 820 and which has successfully undergone many customer audits
