National Evaluation Center Of Quality & Technology In Health S.A. Ekapty

The National Evaluation Center of Quality & Technology in Health (E.K.A.P.T.Y S.A.) is a body supervised by the Ministry of Health and Social Solidarity and is governed by the provisions of the law on public enterprises and organizations (Law 3429/2005), as well as by those concerning the operation of public limited companies. It was found in 1988, as “Research Foundation for Biological Materials” with the distinctive title E.KE.V.Y.L. S.A., while in 2011, it was renamed to E.K.A.P.T.Y. S.A.. Since 1997, it operates as a Certification Body and as a Notified Body for Medical Devices, with identification code 0653 (according to the requirements of Community Directive 93/42), accredited by the National Accreditation System (E.S.Y.D) for quality systems certification activities and medical devices. EKAPTY operates in accordance with the requirements of the ELOT ΕΝ ISO/IEC 17021 standard "Conformity assessment - Requirements for bodies monitoring and certifying management systems” and has Civil Liability coverage for the certification activities it offers. EKAPTY currently evaluates and certifies quality systems in accordance with the requirements of the standards EN ISO 9001, EN ISO 13485 and the Ministerial Decision DY8 / 1348/04. It will soon be able to provide quality system evaluation and certification services, in accordance with the requirements of EN ISO 14001 - Environmental Management Systems, EN ISO 45001 - Occupational Health and Safety Management Systems and EN ISO 15224 - Quality Management System in Healthcare.