By introducing innovative technologically advanced devices we aim at improving surgical procedure outcome efficiency and cost.

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RIM Medical Technologies is registered with the FDA and compliant with Good Manufacturing Practices requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Our manufacturing and sterilization process is validated  based on objectives of  ISO 13485:2016,  ISO 11137-1:2006 and ISO 11137-2:2013 and performed in a clean room Class 8 in ISO 13485:2016 certified and FDA registered manufacturing facility.

The biocompatibility evaluation of our medical devices is conducted in accordance with the FDA “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 International Standard ISO 10993-1 “Biological Evaluation of Medical Devices − Part 1: Evaluation and Testing Within a Risk Management Process.” 

For complete use of standards please contact us (info@rimmedtech.com) and request a TDS.

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We utilize comprehensive monitoring system of external and internal audit to ensure regulatory compliance.

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We provide on-going support at the implementation stage and beyond, working closely with medical personnel - delivering presentations and providing training.

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Please follow the link to read RIM Medical Technologies Quality Policy