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17/09/2013

ARGO is accredited according to ISO13485 Medical Device standard

ARGO is accredited according to ISO13485 Medical Device standard

 

Beginning September the manufacturing department of ARGO B1 was successfully audited by SQS (Swiss Association for Quality & Management Systems) regarding the compliance of the maintained Quality System, already GMP certified (ISO15378:2011), with the EN ISO 13485:2012 requirements.
This harmonized European standard defines the requirements of a quality management system for medical devices in the context of regulatory purposes. The application scope of the standard in ARGO B1 (injection, injection blow and assembling lines) includes design, manufacturing and distribution of Class I medical devices with or without measuring function (dosing cups, dosing spoons & rectal/vaginal cream applicators).
Compliance with EN ISO 13485:2012 comprises an indispensable step for the conformity of these products with the Medical Device Directive requirements (CE marking) which is also controlled by our Notified Body, where necessary (devices with measuring function).
In practice, the same principles as with primary packaging materials for medicinal products govern this standard focusing on risk management for product safety as the absolutely essential element throughout all processes. ARGO strictly adhering to this approach consistently ensures the fitness-for-use of the produced medical devices through the provisions of the certified Quality Management System.