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.
With its expertise in research and development, as well as in the safety of medical devices in MRI, Healtis now offers MRI pretesting. The objective of pre-tests is to conduct a targeted first analysis.
For example, our experience shows that a small implantable passive device (<4cm) containing a magnet, will not show significant heating in MRI. However, the presence of the magnet can lead to potentially unacceptable magnetic interactions (displacement force, torque, demagnetization).
As a first investigation, the manufacturer can choose to perform pre-tests focusing specifically on these interactions between the magnet and the magnetic field of the MRI. We can then determine if design adjustment of the device are necessary or if there are conditions that exist that allow the introduction of this device in MRI without risk to the patient carrying the implant.
These pre-tests do not replace the testing required for regulatory submissions, but they do provide essential information to guide the project quickly and economically.
The usual sequence of pre-tests is as follows:
- Definition of a pre-test plan adapted to specific needs
- MR pre-tests are performed, usually with the presence of the customer
- Delivery of a concise report containing the results
- Support in interpreting these results
For more flexibility, pre-tests are charged according to the time actually spent.
Any questions about this service? Please contact us at firstname.lastname@example.org