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The International Standard ISO 13485 provides a process based model for a regulated environment with a concept of Plan-Do-Check-Act and is more prescriptive in nature which gives assurance to stakeholders on strong implementation of documented Quality Management System and compliances to applicable National and International Regulatory requirements.
Medical Device(s) includes instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings.
For more information and updates in the ISO 13485, keep an eye on the URS website.
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