Ledidi + Revolve Healthcare: From software development to clinical evidence

Revolve Healthcare develops custom software for medical devices and regulated healthcare, combining software engineering with in-house regulatory expertise throughout the development process. With an ISO 13485-certified embedded development model and ISO 27001 certification underway, Revolve helps MedTech companies build software with compliance integrated from day one, reducing regulatory risk, avoiding late-stage redesigns and supporting audit readiness.

At Ledidi, we built our clinical evidence platform around a simple belief: generating robust clinical data shouldn’t require months of setup or enterprise-level budgets. Sponsors deserve direct, real-time access to their own data. And the evidence you generate should stay yours: portable, reusable, never locked inside someone else’s system.

Together, Ledidi and Revolve Healthcare help MedTech companies reduce the gap between product development, regulatory compliance and clinical evidence generation. Instead of managing these activities separately, teams can move through critical development milestones with greater confidence, fewer costly delays and a clearer path towards market readiness.

Why Ledidi and Revolve Healthcare have joined forces

Bringing a medical device or software product to market is one of the most complex challenges in healthcare. For startups and scaling companies without large in-house regulatory teams, the path from concept to compliant product can be slow, costly and uncertain, and software development, regulatory compliance and clinical evidence are too often handled as separate activities. Revolve brings regulatory-first software delivery; Ledidi brings a no-code evidence platform that sponsors control. Working together, we give MedTech teams a clearer route from concept to compliant, evidence-backed product.