Quality Systems
Certificates & Quality Approvals
Download our official ISO certification, Medical Device Directive documentation, and UK MDR 2002 certificates using the links below.
Quality Assurance System
Surgical Holdings operate under robust ISO 13485:2016 quality management systems. Our quality system has been assessed in accordance with Medical Devices Directive 93/42/EEC Annex II requirements, permitting us to CE mark stainless steel orthopaedic implants such as Kirschner wires, Arthrodesis wires, and Steinmann pins.
British Standard Steels & Passivation
We strictly adhere to British standard guidelines BS 5194 Part 1 1991 / ISO 7153-1, never substituting for inferior grade steels. All instruments undergo in-house passivation to eliminate impurities prior to being despatched, ensuring optimal oxidation, washing resilience, and long-term reprocessability.
Our Commitment to Quality
Watch our detailed overview explaining how British manufacturing standards, in-house passivation, and rigorous quality systems drive excellence across all our surgical product lines.
Enquire About Our Standards