Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.
Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.
About the roleAs a member of Scarlet’s expert roster, you’ll be contacted for short engagements (typically a few hours of review or discussion) when your expertise is relevant to a device or assessment question. Your advice will resolve specialist clinical questions so Scarlet can reach sound, evidence-based assessment decisions that help safe devices reach patients sooner.
ResponsibilitiesProvide targeted clinical insight on medical devices during regulatory assessments
Review evidence and discuss assessment questions when your clinical expertise is relevant
Advise on clinical performance, safety and benefit for a device’s intended clinical use
A degree in clinical medicine, nursing or dentistry
Certified specialisation in a medical field
Current registration as a medical practitioner
Skills Required
- Degree in clinical medicine, nursing, dentistry
- Certified specialisation in a medical field
- Current registration as a medical practitioner
What We Do
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
