The medical device regulatory processes have progressed a lot since 2003. ISO 13485 has been affected by the leading medical device regulatory bodies around the world, like the FDA (Food and Drug Administration) in the United States. One of the main reasons that ISO 13485 has been revised is the alignment of the international standard with the common regulatory concepts that have evolved since 2003. ISO 13485:2016 is a voluntary standard for Quality Management Systems of medical device manufacturers and suppliers and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices.

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