Buy ISO 13485 & other Medical Device Standards

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Why aren’t ISO standards free?

Quality Management Systems

Risk Mnangement in Medical Devices

QMS Guidance

Medical Device Software

Why aren’t ISO standards free?

ISO standards cost money to develop, publish and distribute. Someone has to pay. The current system whereby users are requested to pay for the standards they use, not only sustains the development process but also, very importantly, ensures that the balance of independent vs. government, private vs. public interests can be maintained.