The Healtis team is delighted to announce the addition of new methods for assessing gradient heating and vibrations to our testing catalogue. This development represents a significant enhancement of our service offering, particularly for manufacturers and developers of medical devices who need to ensure the safety and compatibility of their implants in the MR environment.
These newly introduced methods have been designed with strict attention to current international standards. For active implants, they fully comply with clauses 9 and 10 of ISO/TS 10974:2018, which specifically address the evaluation of gradient‑induced heating and gradient‑induced vibrations. Both aspects are essential components of a comprehensive risk assessment when a device is exposed to the gradient fields generated by an MRI system. Understanding how an implant behaves under these conditions is crucial for anticipating potential hazards and demonstrating compliance with regulatory expectations.
By integrating these tests into our catalogue, we now offer an even more complete and structured approach to MR safety evaluation. Manufacturers can rely on robust, reproducible data obtained through protocols aligned with internationally recognized requirements. This not only strengthens the technical documentation needed for regulatory submissions but also supports design optimization and a deeper understanding of device performance in real‑world MR conditions.
Whether you are preparing to initiate a new study, expand an existing technical file, or simply gather more information about these newly available methods, our team is ready to assist. Healtis brings extensive expertise in MR safety and compatibility, helping you identify the most relevant tests for your device and interpret the results with clarity and precision. Our goal is to support you at every stage of your project, ensuring that your device meets the highest standards of safety for patients undergoing MRI examinations.
If you have any questions about these new services or if you are planning a project to evaluate the safety or compatibility of your medical device in the MR environment, feel free to reach out to us at [email protected].
