3d
Medical Device Network on MSNTracey Technologies pockets EU MDR certification for vision diagnosticTracey Technologies’ iTrace uses ray tracing technology to obtain precise measurements of the eye’s internal and external ...
2d
Medical Device Network on MSNEMA establish advisory portal for high-risk medical devicesThe EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.
For healthcare firms involved in the spaces of software-as-a-medical-device ... not Class IIa or higher, you’re almost certainly not,” added Gilbert. Similar to complying with the EU MDR ...
For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.
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