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A Practical Field Guide for ISO 13485:2016: Medical Devices--Quality Management Systems--Requirements for Regulatory Purposes

By Erik V. Myhrberg, Joseph Raciti, Brandon L. Myhrberg
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$60.00
By Erik V. Myhrberg, Joseph Raciti, Brandon L. Myhrberg
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The purpose of this expanded field guide is to assist organizations, step-by-step, in implementing a quality management system (QMS) in conformance with ISO 13485:2016, whether "from scratch" or by transitioning from variations of the ISO 13485 family. In keeping with ISO 9000:2015's definition of quality as the "degree to which a set of inherent characteristics fulfills requirements," Myhrberg, Raciti, and Myhrberg have identified the requirements and inherent characteristics (distinguishi...

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BusinessManagement & LeadershipQuality ControlQuality Control - General & Miscellaneous