The startup develops certified software and AI medical devices to enhance healthcare accessibility and affordability. By utilizing AI, the company provides a framework for software developers and regulators to continuously monitor and scale healthcare products effectively.
Funding
$27.6M raised to dateRaised 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.
Founders
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 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.
Target Audience
Scarlet's primary customers are SaMD and AIaMD manufacturers seeking efficient, predictable, and continuous certification to bring their innovative technologies to market.
Features
- Specialization in software and AI medical device certification
- Conformity assessment against EU MDR Annex IX and UK Medical Devices Regulations 2002
- ISO 13485 certification
- AI-enhanced platform for efficient assessments
- Dedicated workspace for file uploads and collaboration
- Clear requests and version control for streamlined communication
- Expertise in IEC 62366-1, IEC 62304, and IEC 82304 standards
- Support for iterative refinement with usability evaluation and integration testing