AQLANE Medical has received EN ISO 13485:2016 certification

06 November 2018

A major milestone, AQLANE Medical has received EN ISO 13485:2016 certification for its Quality Management System (QMS).

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EN ISO 13485:2016 is an internationally recognized quality standard specific to the medical device industry. EN ISO 13485:2016 demonstrates AQLANE Medical’s commitment to the highest level of medical device quality controls and to meeting customer and international regulatory expectations. AQLANE Medical is pleased to offer their services under the EN ISO 13485:2016 certification.

About EN ISO 13485:2016

EN ISO 13485:2016 has been harmonized to the European Medical Devices Directives: MDD, AIMDD and IVDD. EN ISO 13485:2016 replaces the previous version of the standard. Standard harmonization allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.