ISO-13485-HANDBOOK › Medical devices - A practical guide
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This handbook is intended to guide organizations in the development, implementation and maintenance of their quality management system in accordance with ISO 13485. Organizations active in the medical device sector, such as manufacturers, importers, distributors, service providers certification bodies or regulatory bodies, can benefit from this publication.
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03.100.70 (Management systems Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject Including environmental management systems (EMS), road traffic management systems, energy management systems, health care management systems, etc.)
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ISO 13485:2016 - Medical Devices - A Practical Guide
Jan. 1, 2017