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
” 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 a expert team and specific […]
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 : s.parent@healtis.com (USA/Canada time zones) Thibault Klammers : t.klammers@healtis.com (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 […]
FDA guidance “Testing & Labeling”
Updated in 2021, the FDA guidance document “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment” provides FDA recommendations for the risk assessment related to the introduction of medical devices in MRI and the suggested labelling for those devices. Considering these risks is now necessary for regulatory submissions in the United States, […]
Introduction of our assistance service “MRI assessment strategy definition”
Healtis is proud to introduce its MRI risk assessment strategy definition service. Defining your strategy is the first phase of a good MRI risk study, and it is crucial to ensure that the study complies with the requirements and is adapted to the device being assessed. So, what exactly does this service consist of? During […]