The standard ISO 13485:2016, Medical devices – Quality management systems – Requirements for regulatory purposes is a globally recognized standard which is widely used internationally, and which is scheduled for review this year (2025). ISO 13485 is explicitly designed to meet many of the international regulatory requirements for medical devices, incorporating risk management, documentation controls, and design controls specific to the industry. It has been also adopted as the Standard of choice for the MDSAP programme which support 5 main regulatory bodies (Australia, Brazil, Canada, Japan and USA) with further international acceptance.

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