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MEDIPAC Full Quality Assurance System, including the design, manufacture and final inspection of products, is in accordance with the national and international standards of quality and complies with the essential requirements of the Directive for Medical Devices 93/42/EEC.
MEDIPAC Quality Management System (QMS) is structured and operates under the requirements of ISO 13485:2012.
MEDIPAC is subjected to annual inspections by the notified body EKAPTY (National Evaluation Center of Quality and Technology in Health), so as to verify the continued compliance of the applied operations with the requirements of the aforementioned Directive and Standards.
EN ISO 13485 ΔΥ8/1348/04 Free Sales Certificate FULL QUALITY ASSURANCE SYSTEM