FloyMammo × Scarlet
From submission to certification in 5 weeks for an AI mammography device
“Scarlet were amazing. Their communication was so clear and review times so fast. Their support enabled my team to surpass all expectations for the certification timeline, helping bring cardiovascular risk assessments into regular mammography screenings.”
Dr Lea-Elena Braunschneider
Medical Excellence Lead, Floy
The Challenge
Floy wanted to add FloyMammo to their existing EU MDR certificate
Customer Snapshot
•
Innovative, Germany-based AI medical device manufacturer
•
Developed a range of AI-powered medical devices supporting radiologists
•
Adding another IIa device for CE marking
The Scarlet Process
Scarlet's intelligent account management allowed Floy to release multiple AI-driven medical devices
Scarlet’s approach resulted in:
•
EU MDR certification of a cutting-edge device
•
A completed technical-file assessment in just 5 weeks
•
Floy is ready to bring even more innovative devices to the market
“Certification is the bridge between innovation and clinical practice. Scarlet helped us bring another meaningful AI solution to market efficiently. We love working with Scarlet and we can't wait for the next device.”
Dr Lea-Elena Braunschneider
Medical Excellence Lead, Floy
