Clinical Investigation & Performance Study Design
The Catalyst
Turning strategy into studies designed to answer the right questions.
The Catalyst leads the design of clinical investigations under MDR and clinical performance studies under IVDR, ensuring that study objectives, endpoints and execution support intended purpose, claims, regulatory requirements and future market positioning.
The objective is not simply to design a study, but to generate evidence that supports regulatory decisions, strengthens claims and creates long-term value throughout the product lifecycle. Study design is informed by a State-of-the-Art review, alongside the principles of ISO 14155 for medical devices and ISO 20916 for in vitro diagnostics.
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