We at ArcRoyal Ltd., 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 9001: 2008 and ISO/EN 13485: 2003 standards.
ArcRoyal Ltd. 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 Ltd. place medical devices.
All ArcRoyal Ltd. 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.
Awarding of Manufacturer's Authorisation Licence by the Irish Medicines Board
ArcRoyal are pleased to announce that we have been awarded the Manufacturer’s Authorisation Licence by the Irish Medicines Board. This Authorisation Licence now permits ArcRoyal to include certain liquid medicinal products, such as ChloraPrep®, in the Custom Procedure Packs that we produce at our facility in Co Meath, Ireland.
If you require further information about the awarding of this licence, please contact our Quality Manager, Mr Declan Mulvin, who will be happy to answer any questions that you may have.