We have deep expertise in the evaluation of innovative and complex technologies, aligned to current and future regulatory requirements.
The company is built on our relationships and extensive engagement with industry, academics, regulators, government across the ecosystem to ensure we could be agile and efficient whilst meeting the needs of the full spectrum of Medtech innovators. We realise the needs of different organisations vary widely and have worked with the full spectrum of Medtech innovators to deliver bespoke solutions to their needs.
Our regulatory and clinical teams work closely with sponsors to design evidence strategies that meet UKCA, FDA and MDR requirements – today and in the future. From early innovators to major global manufacturers, we have built a solution with you and for you.
Helping innovators generate early evidence to de-risk development and attract investment
Supporting clinical development programmes for regulatory approval and market expansion
Providing robust clinical data to support investment decisions and value creation
Partnering to develop high-quality research that improves patient outcomes and drives innovation
Collaborating on clinical research that advances medical knowledge and practice
Clinical evaluation and real-world evidence for AI-enabled and software and a medical device
Expertise in digital therapeutics, mobile health apps and connected solutions
Deep clinical expertise across joint reconstruction, spine, trauma and sports medicine
Supporting evaluation of robotic systems and image-guided surgical technologies
Evaluation of connect medical devices and interoperable ecosystems
Real-world data, registries and PMCF to demonstrate long-term value and safety