MediRapp × Scarlet
EU MDR & ISO 13485 for a Swiss cardiology startup’s AI medical device
“Dealing with Scarlet’s experts made the process so much better. I especially appreciated that they brought cardiology expertise to the table. Their clinical knowledge was invaluable.”
Dr Paola Daniore
CEO, MediRapp
The challenge
MediRapp needed EU MDR & ISO 13485 certification for their AI-powered Class IIa device
Customer snapshot
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Innovative Swiss startup
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Developed EchoRapp – a powerful echocardiography software for automated measurements and reporting
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Expecting to update and add new models for CE marking
The outcome
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Achieved EU MDR & ISO 13485 certification
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MediRapp benefitted from dedicated Structured Dialogues with Scarlet clinical team
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First change notification to update EchoRapp with a new AI model submitted soon after certification
“We were looking for a Notified Body that would allow us to perform fast updates to our device. In cardiology, this is essential given how quickly guidelines evolve, and in Scarlet that’s exactly what we have.”
Dr Paola Daniore
CEO, MediRapp
