Revolve Healthcare x Ledidi: a new partnership bridging medical software and clinical evidence generation

Bringing a medical device or regulated healthcare product to market requires more than building reliable software. Companies must also demonstrate that the product is safe, compliant and supported by credible clinical evidence.

The challenge is that software development, regulatory activities and evidence generation are often managed as separate workstreams. This creates duplicated effort, fragmented data and costly delays when teams approach certification or market entry.

Our new partnership with Ledidi is intended to close that gap.

Ledidi provides a clinical evidence platform that enables healthcare and MedTech companies to collect, manage and analyse clinical data without building complex research infrastructure from scratch. Its no-code platform is validated for GCP and FDA 21 CFR Part 11 compliance and supported by ISO 27001 and SOC 2 Type II certification.

At Revolve Healthcare, we support MedTech companies in designing, developing and modernising software for medical devices and regulated healthcare products. Our model combines software engineering with regulatory expertise throughout the development lifecycle, helping teams integrate compliance, documentation and risk management from the beginning rather than addressing them before submission. We are ISO 13485 certified and we develop in compliance with MDR/IVDR or FDA and with many industry standards such as IEC 62366, IEC 62304, IEC 82304, GDPR/HiPPA or OWASP.

The real bottleneck is rarely software development alone. It is the lack of continuity between product decisions, regulatory evidence and clinical data.

By combining Revolve’s regulatory-first software delivery model with Ledidi’s clinical evidence platform, companies can approach these areas as one coordinated process. This reduces the risk of inconsistent requirements, disconnected documentation and evidence gaps emerging late in the product lifecycle.

The partnership gives MedTech teams a clearer route from product concept to market readiness, with:

• software development aligned with regulatory expectations from the outset,

• structured access to clinical data and evidence,

• fewer handovers between separate suppliers and systems,

• greater control over documentation, traceability and submission readiness.

For startups and scaling companies without large internal regulatory or clinical operations teams, this means fewer dependencies, better cost visibility and more predictable development decisions.