Provides specialized certification services for software as a medical device (SaMD) and AI-driven medical technologies, serving as Europe’s only Notified Body focused on these areas. Streamlines the regulatory approval process, enabling manufacturers to achieve safe, predictable, and continuous market access for their innovations. Reduces delays in bringing life-changing healthcare solutions to patients by ensuring compliance with EU regulations.
Funding
$7M 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-driven medical technologies face complex regulatory pathways, particularly in the EU, leading to delays in market access. Navigating the EU Medical Device Regulation (MDR) and the upcoming AI Act requires specialized expertise, which can be a significant hurdle for manufacturers.
Solution
Scarlet provides specialized certification services for Software as a Medical Device (SaMD) and AI-driven medical technologies, acting as a Notified Body focused on these areas. The company streamlines the regulatory approval process, enabling manufacturers to achieve predictable and continuous market access for their innovations in the European Union. Scarlet offers a certification process tailored for software and AI, helping manufacturers navigate the complexities of MDR and the AI Act. By ensuring compliance with EU regulations, Scarlet reduces delays in bringing life-changing healthcare solutions to patients.
Target Audience
The primary customers are manufacturers of Software as a Medical Device (SaMD) and AI-driven medical technologies seeking regulatory approval and market access in the European Union.
Features
- Specialization in SaMD and AI-driven medical device certification
- Expertise in EU MDR and AI Act compliance
- Streamlined regulatory approval process
- Support for continuous market access in the EU
- Risk management system implementation and assessment
- Quality Management System (QMS) support, including AI-specific QMS integration
- Technical documentation file creation and maintenance
- Guidance on data management QMS requirements, including data acquisition, pre-processing, labeling, analysis, and storage
- Support for train-validation-test procedures for AI systems