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Iso 13485 2016 pdf12/31/2022 Contact Customer Service for a quote or more information. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library - a personalized collection of FDAnews publications that is fully searchable. Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. Order your copy of ISO 13485:2016 - A Devicemaker’s Transition Guide today. The report interprets the four key areas in the 2016 version - risk management, design control, supplier management and corrective and preventive action - and explains what kind of changes the new standard will require.īased on the insight of one of the world’s foremost ISO experts, this report is essential for any devicemaker that hopes to survive the coming transitions.
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