Scarlet

Scarlet is a Notified Body that certifies Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD). It is, by its own account, the only Notified Body in Europe specialised in software and AI medical device certification. The company offers a certification process built specifically for SaMD and AIaMD manufacturers, and works with medical device manufacturers developing medical software across Europe, the European Union and the United Kingdom.

The certification process is delivered by a team of doctors and engineers and supported by in-house AI tooling, which the company describes as a means of making certification more efficient. Technical work spans software engineering, clinical expertise and AI as applied to medical devices, alongside the regulatory practice of medical device certification.

Scarlet states a mission of hastening the transition to universally accessible healthcare, and describes its work as aimed at enabling its customers' goals and at increasing access to safe and effective software and AI medical devices. The company's website is https://scarlet.cc/.