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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• EN 374-1

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• EN 455-1

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• CE Marking

  CE Marking is a label that shows a product meets certain safety and environmental standards set by the European Union. To get the CE Marking, a company must test and certify their product meets these standards. CE Marking is required for many products sold in the EU, including electronics, machinery, toys and medical devices. It helps ensure that products are safe for consumers and the environment, and allows for easy trade within the EU.