RIM Medical Technologies is committed to enhancing surgical outcomes, operational efficiency, and cost-effectiveness through the introduction of innovative, technologically advanced medical devices.

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Our organization is registered with the U.S. Food and Drug Administration and adheres to Good Manufacturing Practices as outlined in the Quality Systems Regulation (21 CFR Part 820).

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Our manufacturing and sterilization processes are validated based on objectives of ISO 13485:2016, ISO 11137-1:2006, and ISO 11137-2:2013 standards. These processes are conducted in a Class 8 cleanroom within an ISO 13485:2016 - certified and FDA-registered manufacturing facilities.

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The biocompatibility of our medical devices is evaluated in compliance with the FDA’s guidance on the “Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management” (September 8, 2023) and ISO 10993-1, “Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management Process.”

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For detailed information on regulatory standards, please contact us at info@rimmedtech.com to request a Technical and Regulatory Information (TDS).

We maintain rigorous regulatory compliance through a comprehensive monitoring system, including both internal and external audits.

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RIM Medical Technologies provides ongoing support during implementation and beyond, collaborating closely with healthcare professionals through presentations and training programs.

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Please contact us to request RIM Medical Technologies’ Quality Policy.