Quality
We at ArcRoyal are committed to providing our customers with quality products and services in a timely and cost effective manner. To achieve this, we constantly strive to measure, analyse and improve quality in all aspects of our business, through the effective implementation, operation, evaluation and continuous improvement of a comprehensive Quality Management System developed to comply with the requirements of ISO/EN 13485: 2016 standards.
ArcRoyal is committed to maintaining a standard of quality throughout business, which complies with Annex V and Annex VII of the Medical Device Directive (93/42/EEC, as amended per 2007/47/EC) and all the relevant regulations of EMEAA countries, into which ArcRoyal place medical devices.
All ArcRoyal employees are bound by a serious commitment to the stated quality objectives which are developed in line with this quality policy and the requirements outlined in the Quality Manual, which must be adhered to at all times. Our Quality Certificates can be downloaded below.
Medical Device Directive EC Certificate