Perspectum × Scarlet
Triple certificate transfer for precision-health SaMDs
“Scarlet understands AI SaMDs, and that means we can authorise and reach the market swiftly.”
Bhaskar Chikkanna
Director of QARA, Perspectum
The challenge
Perspectum wanted to transfer certificates for three devices on the UK & EU markets to process substantial changes
Customer snapshot
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UK startup, an Oxford University spinout
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Building precision-imaging software that turns standard MRI scans into quantitative maps of organ health
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Wanted to transfer their certificates for three devices
The outcome
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ISO 13485, UK MDR, and EU MDR certificates all transferred successfully to Scarlet
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Market access to EU and UK maintained for three cutting-edge devices spanning Class IIa & Class IIb
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Two certificate changes processed soon after transfer
“Scarlet’s responsiveness and swift turnaround times enable us to be agile in product iterations and help us reach clinicians within our intended timelines.”
Bhaskar Chikkanna
Director of QARA, Perspectum
