![]() This standard also deals with the organization of material vigilance, i.e. The standard is thus intended for distributors, subcontractors, suppliers, manufacturers, repairers and maintenance agents of medical devices.Īs the health sector is undoubtedly one of the most regulated in the world, one of the objectives of ISO 13485 is to set up processes to facilitate compliance with regulatory requirements and ensure maximum product traceability. Within this sector, health risks are high and the regulations in force are particularly abundant - ISO 13485:2016 is an independent standard for quality management for medical devices, and is based globally on the ISO 9001 standard.įacilitate the understanding of regulations A medical device is therefore generally used to diagnose, prevent or even treat diseases. The medical devices concerned by ISO 13485 are machines, products, implants, instruments or reagents used in vitro, i. This is an internationally recognised standard that sets a high level of requirements for your quality management system. ![]() ISO 13485 standard ISO 13485:2016 is a standard for the medical devices sector. ![]()
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