THE RADIANT cersi resources for innovators
A Clear Path to Compliance.
Navigating the regulatory landscape for Digital Health and AI can be fragmented and overwhelming. At RADIANT CERSI, we have structured our support into three practical phases to help you move from concept to market readiness with clarity and confidence.
ORIENT
Understand where your product
sits in the regulatory landscape
using the Regulatory
Navigation MAP
UPSKILL
Build the knowledge you need through masterclasses, case studies, and shared learning from real regulatory journeyS
IMPLEMENT
Use open-access tools
to generate documentation
and plan your next steps
orient
Understand your product’s place in the regulatory landscape.
Before building your evidence, you must define your regulatory requirements. The Orient phase helps you identify your device classification and understand which MHRA, NICE, or NHS frameworks apply to your specific journey.
The Regulatory Navigation Map
Our comprehensive map provides a visual guide to the UK regulatory ecosystem, helping you identify key touchpoints from concept to post-market surveillance.
UPSKILL
Build the knowledge and expertise your team needs to achieve regulatory compliance.
Regulatory success requires more than just a checklist; it requires a deep understanding of the evidence and standards required for your product. We provide expert-led learning and shared insights from real-world regulatory journeys to build your internal capacity for compliance.
Regulatory Science Programme for Innovators: Access our library of on-demand webinars and join the waiting list for upcoming sessions.
Trusted Resources Database: Download our curated, up-to-date directory of core guidance, templates, and toolkits to support your regulatory journey.
RADIANT CERSI Masterclasses: Deep-dive into specific regulatory challenges with sessions led by industry and academic experts.
Access Upskill Resources and masterclasses
implement
Move from strategy to action with practical tools for market entry.
Once you have defined your roadmap and built your internal knowledge, it is time to execute. We provide open-access tools and step-by-step guides to help you generate the necessary documentation and finalise your technical files for regulatory submission.
Regulatory Navigator Prototype
Move from theory to action. Our Navigator helps you structure your regulatory activities, track progress, and ensure no critical steps are missed during development.
qms build guide
A Quality Management System (QMS) is the backbone of regulatory compliance. Use our practical guide to understand requirements and start building a system that supports safe, scalable innovation.