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ISO 13485

What is ISO 13485?

ISO 13485 is one of the standards set out by the International Organisation for Standardisation (ISO). 13485 relates to medical devices and the quality management systems and requirements that they are governed by. Specifically, ISO 13485 looks at the requirements for the design and manufacture of medical devices. When a device, or the organisation that manufactures it, has been deemed legally compliant with the standard, the internationally recognised CE mark can be placed on it.