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Medical Devices Quality Management System ISO 13485 in Noida 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 in Noida 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 in Noida, 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.
“Be advised that as per the new requirement of IAF/ISO Joint Communique Dated 22nd February 2024,In consideration of requirement of clause 4.1 and 4.2 Understanding the context of organisation and needs and expectation of interested parties, it is important for you to determine whether climate change is a relevant issue and consider where interested parties can have requirements related to climate change”