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"The United States and European Union now require the ISO 13485 Standard certification for medical device manufacturers. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control. It covers all the requirements of ISO 13485 and offers a step-by-step comparison between the ISO 13485 and ISO 9001, enabling a sound understanding of these new procedures"--Provided by publisher.
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Editions
5 editions- Other · English · 2018Taylor & Francis Group · 878 pages · 9781138039179
- Other · English · 2017Taylor & Francis Group · 374 pages · 9781138071933
- Other · English · 2012Taylor & Francis · 361 pages · 9781439866115
- Other · English · 2012Taylor & Francis Group · 376 pages · 9781283350570
- Other · English · 2011Taylor & Francis Group · 9781439866122
Medical instruments and apparatusEquipment DesignManufactured MaterialsHandbooks, manualsStandardsEquipment and SuppliesQuality controlQuality control, standards