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ANSI/AAMI/ISO 13485:2016 Handbook

Medical Devices - A Practical Guide, Advice from ISO/TC 210

AAMI has adopted this companion handbook to ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes. It provides users with practical guidance and accurate interpretation of the requirements specified in the standard. This resource replaces ISO 14969. AAMI/ISO 13485:2016, Medical devices - A practical guide, offers device manufacturers step-by-step guidance applicable to the all stages of a medical device's life cycle from gathering customer requirements to design and through to post-market surveillance of devices. This go-to resource is ideal for regulatory, compliance, quality management professionals who are committed to implementing and maintaining a quality management system that is effective and meets applicable regulatory requirements.


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Association for the Advancement of Medical Instrumentation [aami]


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