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.
Document identifier
ISO 13485:2016
Title
Medical devices - A Practical Guide
ISO Category
TC 210: Quality management and corresponding general aspects for medical devices
Publication date
2016-11-01
International Relationship
History of version
ISO 13485:2016 - Medical Devices - A Practical Guide, Advice from ISO/TC 210*ISO 13485:2016 * ISO 13485:2016 - Medical Devices - A Practical Guide, Advice from ISO/TC 210 * ISO 13485:2016 * ISO 13485:2016 - Medical Devices - A Practical Guide
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104 vnd |
ISO 13485:2016
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