Accreditation
Accreditation
Surgins is committed to the provision of quality products and services. We are very proud of the excellent reputation we have gained for consistently providing the best quality instruments on time, every time.
We are registered as a manufacturer of Medical Devices with the MHRA (Medicines and Healthcare products Regulatory Agency). This is an executive agency of the Department of Health and Social Care in the United Kingdom, and is responsible for ensuring that medicines and medical devices meet applicable standards of safety and quality.
Surgins instruments are manufactured to the highest possible standards and are CE marked in compliance with the Medical Device Directive 93/42/EEC.
Surgins operates a Quality Management System in accordance with ISO 13485, the recognised international standard for Medical Devices. We are independently audited by BSI to maintain regulatory compliance.
Surgins is registered with the FDA (U.S. Food & Drug Administration). The Food and Drug Administration is responsible for protecting public health by ensuring the safety, efficacy, and security of medical devices in the USA.
