Commercial Relations - US

Scarlet is Europe's only Notified Body specialised in software and AI medical device certification. The company provides a streamlined certification process built specifically for Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD) manufacturers. Scarlet is authorised and regulated by major government agencies including the UK Medicines and Healthcare products Regulatory Agency (MHRA), Dutch Ministry of Health, and the European Commission. The organisation is designated as an EU Notified Body under Regulation (EU) 2017/745 (EU MDR) and as a UK Approved Body under UK Medical Devices Regulations 2002.

Scarlet's mission is to hasten the transition to universally accessible healthcare by enabling customers to achieve their goals and increasing access to safe and effective software and AI medical devices. The company addresses the critical bottleneck in healthcare innovation: the time required to safely bring new products to market. Scarlet works with visionary medical device manufacturers building the next generation of medical software, helping them safely get updated products to patients who need them. The team is composed of doctors and engineers who deeply understand the technology, armed with in-house AI tools to provide unbeatably efficient certification processes.