
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.

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.
Core offering: Notified Body specialised in software and AI medical devices (SaMD)
Jurisdictions: EU (EU MDR) and UK (UK MDR); recognitions include EEA, Switzerland and Turkey
Certifications offered: EU MDR/UK MDR conformity assessment and ISO 13485
Employees: Approximately 70
Reported total funding: USD 27,750,000
| Company |
|---|
Regulatory certification and conformity assessment for software and AI medical devices (SaMD).
Software Development
Public profiles reference a Seed or Series A round on this date (details vary by source)
Our mission is to hasten the transition to universally accessible healthcare. We are authorised by governments to assess and grant market access to medical AIs. Our groundbreaking approach enables the most innovative technology to reach patients safely and quickly.
Scarlet is the pre-eminent authority on AI medical devices. We serve customers that matter. Companies building bleeding-edge medical AI systems choose Scarlet. We are proud to count the world’s best resourced and most ambitious companies building medical AI as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.
Come help us bring the next generation of healthcare to the people who need it.
About this role: Scarlet’s Quality Team plays a pivotal role in ensuring that Medical Device Manufacturers meet and exceed the Quality Management System (QMS) requirements laid out by the regulators. With deep expertise in regulatory standards, the team designs efficient workflows that enable timely and secure QMS audits of the next generation of Healthtech products.
The Quality Team's goal is to ensure full compliance and operational excellence—both within Scarlet and for Medical Device Manufacturers.
Your responsibilities:
The key skills:
Desirable skills:
The Interview Process
At Scarlet, we have built our interview processes to ensure you get to fully understand the role and Scarlet’s culture, and to ensure we get to know about your skills, expertise, and who you are. Here is what to expect:
Compensation Range: £60K - £80K