Clinical Specialist
Scarlet
Clinical Specialist
Scarlet
Certification framework for software medical devices
Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.
Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.
As a member of Scarlet’s expert roster, you’ll be contacted for short engagements (typically a few hours of review or discussion) when your expertise is relevant to a device or assessment question. Your advice will resolve specialist clinical questions so Scarlet can reach sound, evidence-based assessment decisions that help safe devices reach patients sooner.
Provide targeted clinical insight on medical devices during regulatory assessments
Review evidence and discuss assessment questions when your clinical expertise is relevant
Advise on clinical performance, safety and benefit for a device’s intended clinical use
A degree in clinical medicine, nursing or dentistry
Certified specialisation in a medical field
Current registration as a medical practitioner
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.
Explore more opportunities at Scarlet