HEALTIS SAS

We offer a wide range of tests for evaluating the safety of medical devices in the MRI environment, including: 

ASTM F2052 - Measurement of the displacement force generated by the static magnetic field
ASTM F2213 - Measurement of the torque generated by the static magnetic field
ASTM F2182 - Measurement of the Radio Frequency induced heating
ASTM F2119 - Evaluation of the image artifacts generated by the presence of the device

& 

ISO / TS 10974
Clause 8 - Assessment of radiofrequency heating
Clause 9 - Assessment of gradient field heating
Clause 10 - Evaluation of vibrations
Clause 11 - Measurement of the displacement force induced by the static magnetic field
Clause 12 - Measurement of the magnetic torque induced by the static magnetic field
Clause 13 - Assessment of gradient field induced currents
Clause 14 - Assessment of malfunctions due to the static magnetic field
Clause 15 - Assessment of radio frequency induced malfunctions
Clause 16 - Assessment of gradient field induced malfunctions
Clause 17 - Assessment of the combined field effects (possibility to monitor implant activity)
Clause 18 - Evaluation of the image artifacts generated by the presence of the device

Medical devices may experience an increase in temperature as a result of the radio frequencies present during an MRI exam.

Evaluation of this radio frequency heating is mandatory when the device is in contact with the patient. The heating depends on multiple factors: physical characteristics of the device, characteristics and settings of the MRI, positioning of the device vis-à-vis the machine, implantation conditions for an implantable MD, … etc.

The evaluation of the heating can therefore be complex. The use of numerical modeling simplifies and consolidates these studies. HEALTIS is expert in this field and can accompany you:

To determine worstcases in ranges of passive devices with multiple configurations
to determine the points of maximum heating on a device
for specific studies requiring the modeling of radiofrequency heating.

HEALTIS is a leader in evaluating the safety of medical devices introduced in the MRI environment. Our experts participate in the development of new knowledge and the development of standards in the field. This allows us to be at the forefront of knowledge in the evaluation of interactions between MRI and medical devices but also to anticipate changes.

Through contact with our customers, we have also acquired expertise in the regulatory requirements for the marketing of medical devices, in all international markets.

This makes HEALTIS the ideal companion to maximize your chances of having an irreproachable assessment of the safety of your product in MRI. This accompaniment by an expert is offered from the first contacts with HEALTIS. If your project requires it, we will be able to offer you technical and regulatory assistance services. These benefits may take the following forms:

• Proposed Risk Assessment Strategy
• Determination of the worstcases
• Writing Rationals
• Interpretation of results and marking of the device according to ASTM F2503
• Audit of your risk assessment in MRI and proofreading of documents

Offering a device compatible with an MRI environment can be a real competitive advantage. For some products it has even become indispensable.

Taking into account the safety aspect in MRI in the design of a product is complex for the manufacturer. This requires skills that are not always available internally: in-depth knowledge of MRI, interactions between electromagnetic waves of MRI and devices, knowledge of material physics and electronics. This may also require tests on prototypes, with suitable testing means.

As experts in the field, our engineers and doctors can guide you during these phases of R & D, as much on the technical as regulatory aspects. So you focus on your skills and we bring you additional skills to carry out your project. The project will benefit from better control of costs and deadlines.

Wishing to share our knowledge, our training aims to help you develop skills in assessing the safety of MRI devices. We then discuss the technical, scientific and regulatory aspects of the safety and compatibility of medical devices in the MRI environment. Here are some examples of themes we can deal with:

• the risks generated by the interactions between the Medical Device and the electromagnetic waves of the MRI
• applicable regulations and test methods for evaluating the safety of a Medical Device in MRI
• Integration of MRI compatibility into product design

These training courses are tailor-made to be adapted to your problem, your products and your level of knowledge. They usually take place on our premises, which allows us to illustrate our subject by carrying out practical work in the MRI environment.

You will be trained by one or more expert(s) of HEALTIS, member(s) of the normative groups of the domain.