ISO 13485: medical devices - quality management systems - requirements for regulatory purposes
ISO 13485 (medical devices-quality management systems-requirements for regulatory purposes) is an international standard that presents the requirements for a quality management system specific for the realization of medical devices, including software systems with medical purposes. For the reminder of the chapter, we will refer to ISO 13485:2016, which is the latest available version of the standard.
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ISO 13485: medical devices - quality management systems - requirements for regulatory purposes, Page 1 of 2
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