The certification consists in the verification, by a third party body, independent and accredited, of the compliance of the Quality Management System with the requirements of the international standard UNI EN ISO 9001 and 13485 for medical device.
MEDENCY’s certification is functional to its organization in a view of continuous improvement and efficiency of processes, human resources and structures, to the benefit of patient and health care professional safety.
Our Quality Management System (QMS) is based through a continuous improvement of products, services, and interactions for the highest quality and greatest value. For more details about our quality management system, regulatory compliance and our commitment to continuous improvement see our COMPANY POLICY
Additional information regarding Medency Certificates:
EC QUALITY ASSURANCE
ISO 9001:2015
ISO 13485:2016
