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, navigating the path from concept to compliant product can be slow, costly, and uncertain.
These companies deserve a clearer route. That’s the shared conviction behind our new partnership with Revolve Healthcare.
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.
Our no-code platform is validated for GCP and FDA 21 CFR Part 11 compliance, with ISO 27001 and SOC 2 Type II certification.
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.
“We are delighted to announce our partnership with Revolve Healthcare. They share our conviction that regulatory compliance and clinical evidence generation shouldn’t be barriers to innovation — especially for the startups and scale-ups driving some of the most exciting advances in medtech. Together, we can help teams move from concept to compliant product with greater confidence and significantly less friction. This is exactly the kind of partnership that strengthens our mission to make high-quality clinical evidence accessible to innovators across international markets.”
— Einar Martin Aandahl, CEO and Founder of Ledidi
“One of the biggest challenges we see in MedTech is that software development, regulatory compliance and clinical evidence are too often managed as separate activities. That creates unnecessary complexity, duplicated work and delays later in the product lifecycle. By combining our regulatory-first software delivery with Ledidi’s evidence platform, we can help companies move towards market readiness with greater predictability and confidence.”
— Przemysław Grzywa, co-CEO of Revolve Healthcare