Founder
Scarlet
Scarlet is a global certification body that helps medical device manufacturers obtain regulatory approval for AI-enabled software and medical devices. The company offers conformity assessments under EU MDR, UK MDR, and ISO standards, with an AI-enhanced platform designed to accelerate certification timelines and support frequent software releases.
- Regulatory & Compliance Technology
- Artificial Intelligence
- Enterprise Software
- Healthcare Technology
- Software Only
Updated 23 days ago
Funding
Raised to date
$50MRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
across 1 round
RoundDateAmountValuationInvestors
Founders
James Dewar
Co-founder
Product
Problem
Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD) manufacturers face significant hurdles in navigating the complex and evolving landscape of medical device certification. Traditional certification processes can be slow, costly, and ill-suited for the iterative development cycles common in software and AI, delaying patient access to potentially life-changing technologies.
Solution
Scarlet provides specialized certification services for SaMD and AIaMD, streamlining the path to regulatory approval and market access. As a designated Notified Body and Approved Body, Scarlet offers conformity assessments against EU MDR Annex IX and UK Medical Devices Regulations 2002, respectively, as well as ISO 13485, ISO 27001, and ISO 42001 certification. The company's AI-enhanced platform and team of medical-software experts accelerate the certification process, enabling manufacturers to safely, predictably, and continuously deliver the latest versions of their products. Scarlet's approach is optimized for fast-paced development, allowing for frequent updates and improvements while maintaining compliance with stringent regulatory standards. Customers have reportedly cut a year or more from their certification timelines for new AI-enabled devices and shortened product-update cycles from months to weeks.
Target Audience
Scarlet's primary customers are SaMD and AIaMD manufacturers seeking efficient, predictable, and continuous certification to bring their innovative technologies to market, with a focus on companies that need to ship frequent software releases.
Features
- Specialization in software and AI medical device certification
- Conformity assessment against EU MDR Annex IX and UK Medical Devices Regulations 2002
- ISO 13485, ISO 27001, and ISO 42001 certification
- AI-enhanced platform for efficient assessments
- Dedicated workspace for file uploads and collaboration
- Clear requests and version control for streamlined communication
- Support for iterative refinement with usability evaluation and integration testing
- Expertise in IEC 62366-1, IEC 62304, and IEC 82304 standards
- Pre-application verification process with eligibility and risk classification checks
- Stage 1 and Stage 2 audits, plus surveillance, unannounced, and recertification audits
- Certification for medical devices of risk classes Im, IIa, IIb, and III