Helping you navigate MRI safety from strategy to submission ...
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
We also support some customers in the design of DM compatible with an IRM environment -> see R&D support
Proposed MRI Risk Assessment Strategy
There are more than a dozen potential interactions between the electromagnetic waves of the MRI and any product introduced into the examination room (forces, overheating, dysfunctions, vibrations, artifacts, …). A relevant evaluation of the risk in MRI begins with a good risk analysis, the realization of which requires a lot of knowledge: the device and its clinical use, the physical phenomena involved, the regulatory aspects, the test methods, etc.
Each risk chosen must then be evaluated appropriately: rational writing or conducting tests on a worst case scenario.
We propose to support you in this step of strategic definition of your project of evaluation of the risk in MRI, so that your study is most relevant.
Assistance in determining worstcases
The determination of the worstcases for the tests can prove to be complex, in particular for the devices with multiple configurations (different sizes, materials, design, clinical situations, …). In MRI, this worstcase will not necessarily be the same depending on the phenomenon studied.
We propose to assist you in this step, by providing expertise that can implement digital modeling if necessary.
It is sometimes wise to evaluate a level of risk by a scientific argument. As experts in the physics of MRI, we propose to accompany you for the writing of these arguments.
Interpretation of results and device marking according to ASTM F2503
Our tests measure the level of an interaction, the force of displacement for example, but what about the risk incurred by the patient and the information given to clinicians?
Our interpretation of the results and the marking of the device consists in producing a report that you can use in your regulatory files. This will reflect the chosen evaluation strategy, the justification of the worstcases, the resumption of test results and other rational, the interpretation of these results and a proposal for marking the device according to ASTM F2503 (MR Safe / Labeling). Unsafe / Conditional).
Audit of your risk assessment in MRI and proofreading of documents
Our expertise allows us to have a critical eye on your study of the safety of MRI devices. At your request we will be able to carry out any proofreading of documents in view of the standards in force and the state of knowledge in the security in MRI