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ISO 13485 Series – Medical Devices Quality Management Systems
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Overview

Standards are a set of rules, guidelines or specifications developed by standardization organizations, such as ISO (International Organization for Standardization), that establish criteria and requirements for a particular industry, process or product. Standards provide a common language and framework for different organizations, stakeholders and countries to work together, communicate and ensure interoperability.

There are many different types of standards, including Technical standards, Management standards, Industry-specific standards, National Standards, International Standards and Company Standards.

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