ISO 13485 is an International Standard for Effective establishment and implementation of Medical Device Quality Management Systems.

How it works
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ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements

Who can use
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Organizations which are involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support) can go for this ISO 13485 implementation.

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ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

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Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.

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