ISO 13485:2016
The ISO 13485 standard sets requirements for quality management in the development of medical devices and for the implementation of related services, in order to comply with customer requirements and applicable legislation.
ISO 13485 is a sector-specific standard, and compared to ISO 9001 its main accents are:
Document ISO / TR 14969: 2004 provides guidance on the application of the quality management system requirements contained in ISO 13485. To this end, it contains explanations that help to better understand the requirements and presents methods and approaches suitable for fulfillment of requirements.
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