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ISO 13485:2016 Medical devices -- Quality management systems

ISO 13485 is published in 2016, that speaks to the prerequisites of a thorough administration framework for the outline and production of therapeutic gadgets. Standard supersedes prior reports, for example, EN 46001 and EN 46002 (both 1997), the ISO 13485 distributed in 1996 and ISO 13488 (additionally 1996).

The essential goal of ISO 13485 was to encourage blended restorative gadget administrative prerequisites for quality administration frameworks. ISO 13485 is a standalone standard. It is generally focused around the structure of ISO 9001, however incorporates some specific prerequisites for medicinal gadgets, for example, hazard dissection, sterile assembling and trace ability.



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