DIESSE Diagnostica Senese SpA has worked for many years in accordance with its quality management system certified UNI EN ISO 9001: 2008 Quality Management Systems and UNI EN ISO 13485 Quality Management System for Medical Devices.
Ensuring traceability, transparency, conformity of production and also the quality of its products and services, focusing on continuous improvement.
The products are CE marked under European Directive 98/79 / EEC on in vitro Medical Devices and related applicable harmonized standards.
The requirements of the Canadian MDR.
CE mark certificate: The CE mark of medical devices allows the introduction in the market, employment in the Italian territory and free circulation within the EU. To export in vitro medical-diagnostic devices (IVD) in countries outside the European Union, the Ministry of Health issues a free sale certificate (FSC) "certificate of CE marking."
ISO 9001 certification: ISO 9001 certification ensures that the company is able to meet customer’s expectations in a coherent and complete way. The company guarantees to achieve improvement in terms of organizational efficiency and product quality minimizing waste, avoiding errors and increasing productivity.
ISO 13485 certification: ISO 13485 is a specific quality management system standard for companies in the medical sector: it includes aspects of ISO 9001 standard and specific requirements for the medical devices sector.
The Medical Device Single Audit Program (MDSAP) certificate indicates that a manufacturer complies with the regulatory requirements for the markets defined in the certificate. In case of Diesse all 5 participating Regulatory Authorities are covered: Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA (Japan), and the US Food and Drug Administration (FDA).