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MEDICAL DEVICES regulatory requirements and legal obligations characterize the importance to protect consumers through the application of a internationally recognized and generally accepted benchmark Quality Management System for Medical Devices (QMSMDD) ISO 13485 2016 (ISO publication namely Medical devices - Quality Management Systems Requirements for Regulatory Purposes); it does not intended to replace laws and regulations but to be a helpful aid. For Regulatory Purposes is a helpful aid for organizations to follow legal and regulatory requirements (whereas ISO 13485 becomes a management tool). Current year revision of ISO 13485 is 2016.
BRSTM management services help contractors and manufacturers supplying OEM medical devices whether Class I, II or III to set controls to comply with medical devices on world markets (excludes CMDCAS). While ISO 13485 takes the ISO 9001 approach both are exclusive as the ISO publication determines.
BRSTM approach is to contribute to the organizations ability to identify and manage independent and risks free of conflict of interest. BRSTM expertise in Medical Devices and Medical Sectors with residence operations in Euro Asia (Istanbul-Türkiye), Middle East (Tehran), North Africa (Istanbul), Africa (Luanda), Asia Pacific (Malaysia), Canada (Toronto), South America (Colombia), and North America (based California) - contact us for updates.
QMS MDD client-organizations assessments applies ISO 13485 as a basis to a legally binding charter to protect communities and consumers worldwide. For information on ISO 13485 and regulatory authority visit imdrf.org
While specific groups lobby to mandate that the full medical supply chain be require certification, OEM in the U.S.A. organization still hold the power to decide, as brand appropriately and effectively protect consumer-patients.
BRS assessment-audit attests and when a client-organization successfully adheres to applicable laws and regulation while addressing QMSMDD ISO 13485 a certificate of registration is issued. The basis of applicability is the law and regulations, not ISO 13485 (point-of-origin and point-of-sales).