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Welcome to BRS Quality Medical portal:
As consumer-centric QMS MDD based ISO 13485 2016 provides evidence of your organization’s commitment to the safety and effectiveness of medical devices as it is for regulatory purpose (in the U.S.A. is. QSR 21 CFR 820, and similarly in other sovereign nations medical devices regulations), for Tier suppliers to OEM. We provide quality management system assessment for legally binding regulatory purpose based on the application of current ISO 13485 in adherence to applicable regulations; is to attests that through assessment your Quality Management System (QMS) is found compliant to applicable regulations.
In adhering to QSR (21 CFR 820) contractors, suppliers and OEM address processes of manufacturing and production from design & development, validation, verification onto product homologation and onto product support. ISO 13485 provides a management tool for the identification, implementation, processing and recording in addressing laws and regulations, this is why the specific name “Medical Devices - Quality Management Systems - Requirements for Regulatory Purpose. ISO 13485 does not substitute laws and regulations.
ISO 13485 provides medical devices designers, developers and manufacturers a tool to helps with addressing QSR in the U.S.A. and similarly regulatory requirements in other countries. We need be aware that ISO 13485 2016 does not follow Annex SL Higher Level Structure as ISO 9001 and others followed.
Then why utilize management tool QMSMDD ISO 13485?
Upon an independent third-party service provider ISO 13485:2016 registration attests to an organizations follows a process-based approach adhering to contemporary preventive principles benefitting client-organizations as well as the respective community of consumers-patients. And further:
QMS MDD - Quality Management System for Medical Devices based ISO 13485, additional information.
Please inquire with us on whether we can provide the specific services that you need within your role in the medical devices supply chain.