Scarlet

““We transferred to Scarlet because our mission is to detect cancer as early as possible. We need to be able to update our devices regularly and without friction.””

“That’s what’s great about working with Scarlet, FraiyaScan is an AI medical device, so we want to update it regularly and we know they’re the right Notified Body to facilitate that.”

“We wanted a Notified Body that would understand our SaMD, and that’s why we chose Scarlet. Their process made everything clear, and was aligned to how we develop and update our AI models. With CE marking achieved, we’re now moving fast towards real-world impact in prenatal care.”

““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.””

““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.””

““Even with several regulatory projects running in parallel, Scarlet's customer support meant that everything was really well coordinated and easy to manage.””

““Scarlet have a very strong understanding of AI medical devices and their regulatory context, it made working with them for our devices very straightforward.””

““We want to release upgrades to our medical device twice a month. We can with Scarlet. No one else can deliver that.””

““Scarlet have built a Notified Body for the AI world. The ability to release more rapid and frequent upgrades to our medical device ensures that our patients always have access to world-class care.””

““Our certification journey with Scarlet was streamlined and efficient. They are really responsive, and the fact they’re AI specialised made for such a smooth and effective assessment process. That drastically increased the impact we were able to have with
PlethAI.””

““We were facing a long and uncertain wait to get a truly ground-breaking device to market. Scarlet’s focus as a Notified Body on AI & SaMD meant we could release it in
time and start changing lives for the better.””

“Obtaining CE marking is a critical step towards achieving our mission and Scarlet were a huge part of that. They were such a pleasure to work with.”

“Scarlet always communicate the right information to us at the right time so that we know what's happening. Their team is so dedicated.”

““It’s great to work with a Notified Body that truly understands AI.””

““Working with Scarlet actually led to us creating higher quality SaMD. Their expert feedback meant we refined our work and built better versions of our products.””

““Scarlet get AI. If you have an LLM-powered device, they’re the only choice.””

““Scarlet felt like a true partner. We always knew they were there if we needed their support. That made all the difference for this historic certification.””

““Scarlet’s responsiveness and swift turnaround times enable us to be agile in product iterations and help us reach clinicians within our intended timelines.””

““Scarlet understands AI SaMDs, and that means we can authorise and reach the market swiftly.””

““Scarlet's ability to innovate and adapt allowed DeepHealth to maintain regulatory compliance across a number of complex integration and expansion projects.””

““With Scarlet there’s been a real sense of: ‘Listen, we want to see you be successful as well, so how do we make that happen?’””