Quality Systems

You can download our ISO 13485 certificate here and our Medical Device 93/42/EEC Certificate and MDD extension Confirmation Letter here and our UK MDR 2002 certificate here.

Surgical Holdings have ISO 13485:2016 quality systems in place. Our quality system has been assessed and was found to be in accordance with the requirements of the Medical Devices Directive 93/42/EEC Annex II, this means that we are able to CE mark stainless steel orthopaedic implants such Kirschner and Arthrodesis wires/Steinmann Pins.

Surgical Holdings believe in using the right steels for the correct surgical applications and our instruments are manufactured to British standard guidelines BS 5194 Part 1 1991/ISO 7153-1 (Surgical instruments. Specification for stainless steel) and will not substitute for poorer quality steels, where the instrument requires British standards specification only. This also ensures that our instruments wash and reprocess, as they should. In-house, we passivate all instruments to ensure that all impurities in the steel are detected prior to the instruments being despatched and the steels are appropriately oxidised. As important as instrument quality, is your service, which we also approach in the same manner.