The ISO 13485:2016 standard identifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies.
The ISO 13485 certification is an evidence of Quality Management System compliance to the standard for organizations involved in the Medical Device industry. This approach is not only followed by Medical Device Manufacturers but also supporting organizations such as Subcontractors, Suppliers, European Authorized Representatives, specialized Consulting firms etc.
The EN ISO 13485:2016 certification was awarded by the International Organization for Standardization, the world's largest developer and publisher of worldwide quality and safety standards. This certification outlines specific needs to establish and execute a structured quality management system for medical devices across all areas, from development to deliver.
Benefits of ISO 13485 Certificate
Optimization of costs – reduction of operating costs, decrease of nonconforming products costs, raw materials, energy and other resources savings, Simplifying the procedure of attestation of conformity to needs of EU directives and corresponding Government Orders; Improving trust of public and public monitoring bodies in respect of the medical devices manufacturer. Attestation of efficiency and helpfulness of the established quality management system by an self-governing third party; Guarantee of production procedure stability and thus steady and high quality of services and products supplied to clientele;