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ISO 13485:2016 Consulting

ISO 13485:2016 Consulting

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.

IATF 16949:2016 ISO certification

The required processes that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

Some of the key aspects of ISO 13485 include:

We specialize in implementation assistance along with in-house or public training workshops.

The following ISO 13485 workshops are now available:

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