MRI Pretesting : a targeted first analysis to investigate on induced risks due to medical devices in MRI
Introduction 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. […]
Healtis is in the news!
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!
New update for the ASTM F2503 standard!
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 […]
Healtis will once again be exhibiting at Medica / Compamed trade fair in Düsseldorf!
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 […]
Update of the FDA guidance document “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment”
📣 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 guide is a valuable resource for medical device manufacturers wishing to assess the safety of […]
Check out the interview with Pauline Ferry, Technical Manager at Healtis!
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 […]
Numerical modeling: reliability, experience and dedicated tools
At Healtis, we have a expert team and specific tools dedicated to the numerical modeling of heating due to the radiofrequency fields in MRI. For implantable passive devices, numerical modeling allows us, for example, to predict the worst-case across complex ranges of devices, and also to determine the «hots spots» (Points on the device where […]
Have you ever assess the MRI safety of your medical devices?
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 : [email protected] (USA/Canada time zones) Thibault Klammers : [email protected] (Europe)
Healtis thanks you for your trust and loyalty!
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 […]
Update RE: ASTM F2503 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment)
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 […]