ISO 13485

Medical Devices

ISO 13485 specifies requirements for a Quality Management System to produce ISO medical devices and related services that meet customer requirements. The regulatory requirements of ISO 13485 apply to all suppliers, regardless of company size or type, except where explicitly stated. The current version of the ISO 13485 standard is 13485:2016. This is stand-alone certificate which aligns with ISO 9001:2008, not the more recent ISO 9001:2015. ISO 13485 is also a global standard which is mandatory in some countries.

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Benefits of ISO 13485

To implement the ISO 13485, you need:

The Certification Process for ISO 13485 will include

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