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Europe’s only Notified Body specialised in software and AI

HealthcareRegulationSoftwareAI
Company overview

About Scarlet

Scarlet certifies software medical devices. We are Europe’s only Notified Body specialised in Software & AI. Our mission is to hasten the transition to accessible, affordable healthcare. We strive to achieve our mission by enabling our customers to deliver on theirs, and get their life-changing technology to the people who need it. Scarlet was built specifically for software and AI medical devices. We help customers to get their SaMD certified in the EU & UK, and ship the kind of regular updates inherent to good software, ensuring patients can safely get the most up-to-date technology. Scarlet is designated as an EU Notified Body under regulation (EU) 2017/745 (EU MDR). And a UK Approved Body under UK Medical Devices Regulations 2002 (SI 2002/618 as amended). Scarlet is also accredited to issue ISO 13485 certificates.

Purpose

Mission and direction

Scarlet certifies software and AI medical devices, striving to hasten the transition to accessible, affordable healthcare by enabling life-changing technology to reach those in need. As the only specialized Notified Body in Europe, Scarlet ensures safe, updated technology through efficient conformity assessments in the EU & UK, maintaining ISO 13485 accreditation.

How they work

Company values

  • Innovation
  • Quality
  • Efficiency
  • Safety
  • Accessibility