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Medical Devices Quality Management System ISO 13485 is an effective management tool to address risk throughout the production process and ensures compliance to regulatory, safety and medical product related requirements. ISO 13485 Certification by URS is well recognized worldwide and is accredited by international accreditation board i.e. UKAS.
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.
By implementing ISO 13485 , Organization demonstrates its control over highly regulated and safe environment of their facilities directly related to medical device(s) life-cycle, meeting national and international regulatory compliances.