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@example.com (USA/Canada time zones) Thibault Klammers : firstname.lastname@example.org (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 & Labelling”
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 […]
Throwback to our Healtis anniversary!
In November, the whole team gathered at the “Academie des Chefs” in Metz, for the special occasion of HEALTIS’ 10th anniversary!An opportunity for everyone to celebrate, socialize and learn some new cooking techniques!
Guillaume Paillart gives his feedback about his short internship at Healtis!
Guillaume Paillart is a PhD student at Laboratoire IADI for the “ELECTRA” project (topic : MRI imaging of electrical properties, application to MRI compatibility of medical devices)He carried out a short internship in our premises, and you will find below his testimony : “I had to complete a 7-week internship in a company to validate […]
Healtis will be present at AAOS Las Vegas!
Attention all manufacturers of Orthopaedic Implants! Healtis is excited to announce that we will be back at AAOS this year, happening in Las Vegas next week! Orthopaedic implants represent a large percentage of implanted medical devices and so we are very much looking forward to discussing the importance of MRI safety and compatibility testing in […]
A new member to the team!
We are delighted to welcome a new member to the team!Walid BOUZID, a PhD student as part of a CIFRE Convention between 3 laboratories: HEALTIS, IADI and LEMTA.Walid’s research project is the characterization of the #MRIsafety of medical devices regarding radiofrequency emission.Welcome Walid!
A few details about the magnetically induced Force testing!
Alice Rousseau, our MRI test engineer, tells you a little bit more about the magnetically induced Force testing. ” Healtis carries out the assessment of the MRI static magnetic field induced displacement force on a medical device, according to ASTM F2052; the latest version of which was published in 2021. We conduct this test using […]