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MRI Pretesting : a targeted first analysis to investigate on induced risks due to medical devices in MRI

Introduction 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. […]

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Update of the FDA Guidance “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 guidance is a valuable resource for medical device manufacturers wishing to assess the safety of their products in […]

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