ISO 13485

Healthcare Management Systems

The ISO 13485 Quality Management System for medical devices, appliances and equipment operates in the context of quality management principles throughout the life cycle of medical devices, from development to disposal. Key aspects are, in addition to the basic requirements based on the requirements of ISO 9001, broad-spectrum risks, traceability in the process of manufacturing and distributing medical devices, which are assessed to meet the requirements of the Medical Devices Directive no. 93/42 EEC.

Certification, as an impartial and objective assessment of the compliance of individual or integrated management systems, is performed only by accredited practitioners, with competence for the relevant scope, who are regularly calibrated to the latest knowledge and experience in the field. The certification for which we are internationally accredited concerns management systems according to ISO 9001, ISO 13485, ISO 14001, ISO 200001, ISO 22001, ISO 22301, ISO 27001, ISO 45001.

The certification details that you will not find on this page are listed on the main page at or could be communicated with the G-Cert-i regional representative.