Overview
Scarlet provides a platform-based service for certifying Software Medical Devices. It targets manufacturers of medical software and regulatory bodies, offering a framework that enables scalable, continuous development and monitoring of software products to meet regulatory requirements. The platform streamlines the certification process by allowing both manufacturers and regulators to build, certify, and oversee software in a coordinated, ongoing cycle rather than a one-time check. Scarlet differentiates itself by addressing gaps in the current regulatory approach to fast-evolving health software, emphasizing scalable, continuous monitoring and collaboration between sponsors and regulators. Its goal is to get safe, life-saving medical software to patients faster while helping make healthcare more accessible and affordable for people everywhere.
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Simplify's Take
What believers are saying
- Scarlet certified TORTUS's first UKCA Class IIa ambient voice device on 24 June 2026.
- Scarlet's 3 September 2026 blog cadence signals active demand from AI device builders.
- LinkedIn showed 8,814 followers and 51-200 employees on 31 August 2026.
What critics are saying
- Scarlet depends on regulated-review volume; slower MDR filings hit revenue within 12 months.
- Tougher scrutiny after TORTUS's 24 June 2026 UKCA IIa certification compresses turnaround expectations.
- One high-profile certification failure would destroy Scarlet's trust moat and notified-body franchise.
What makes Scarlet unique
- Scarlet issued its first EU MDR certificate on 13 November 2024.
- Scarlet is UK Approved Body 8536 and recognized for FDA 3P510k reviews.
- Scarlet certifies AI medical software for EU MDR, UK MDR, ISO 13485.
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