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The exposure of a medical device to the MRI environment may induce risks, especially when the device consists of conductive, magnetic or metallic materials. These risks must be assessed to meet regulatory requirements in most markets.For regulatory affairs, testing is required. However, while essential to accurately assess risks, testing is often time-consuming and costly. With […]

Healtis is in the news ! Thank you to DeviceMed for sharing this article as part of the Medica / Compamed trade fair coming up next week, from November 13th to 16th !  This introduction highlights how Healtis can be of assistance when defining your MRI risk assessment strategy. A project, or question? Reach out now!

Do you currently have a medical device labelled for MRI Safety on the market? You should be aware that ASTM F2503 standard defining the Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment has just been updated. The current revision being ASTM F2503-23e1. This update is a small […]

We are delighted to announce that, once again, Healtis will be present at this year’s upcoming Medica/ Compamed trade fair in Düsseldorf! From November 13th to 16th, we will be pleased to discuss the MRI safety and compatibility of your medical devices and any other MR safety topic related to your project at stand 8BE14-6 […]

📣 We would like to inform you of the recent publication of an update about the guidance „Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment“ by the #FDA (Food and Drug Administration). 📚 This FDA guidance is a valuable resource for medical device manufacturers wishing to assess the safety of their products in […]

Our Technical Manager Pauline Ferry answers a few questions about her career and her current position within the Healtis team!Read the interview below: 1/ First of all, where are you from?My father is from Lorraine and my mother from Burgundy, I mainly grew up in Lorraine, in Nancy. 2/ Can you describe your career in […]

In MRI environment, the radiofrequency heating of implanted medical devices can be significant, and may be a risk for patients. This heating is acute and depends on multiple factors, thus for multi-configurational devices, it is often impossible to predict the worst-case by a simple rationale. At Healtis, we have an expert team and specific tools dedicated to the numerical modeling of heating due to […]

Have you ever assess the MRI safety of your medical devices? Should you have any questions about this matter, feel free to reach out at any time : Spencer Parent : s.parent@healtis.com (USA/Canada time zones) Thibault Klammers : t.klammers@healtis.com (Europe)

Since 2020, Healtis has been delighted to contribute to over 300 MR safety/compatibility assessment projects for medical devices. 98% of our customers are “very satisfied” or “satisfied” with our services, and 100% would recommend Healtis for an MR safety/compatibility assessment.The Healtis team is proud to have achieved such positive results and would like to thank […]

Healtis would like to inform all medical device manufacturers that on May 25th of this year, a new version of the MRI Labelling document ASTM F2503 ‘Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment’ was issued. Healtis is currently studying the impact this new version has on […]