Standards and labels

• EN 13485:2016

  EN 13485:2016 is a standard for a Quality Management System for Medical Devices. It sets out the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements. This standard is used to demonstrate a company's ability to meet specific quality and safety requirements for the design, production, installation and servicing of medical devices. Test results can include audits and inspections of the organization's facilities, processes, and products to ensure compliance with the standard.

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