Adionalabs Verified Organisation

In medical-device R&D, the evidence that proves a design is safe and ready (requirements, risk controls, test results, claims, approvals) ends up scattered across dozens of documents and tools. Teams usually find out what's missing the hard way: during an audit, a notified-body review, or the week before a submission deadline. AdionaLabs surfaces those gaps earlier. You upload your design-control package and it rebuilds the links between everything, producing an evidence graph and flagging where readiness actually breaks: claims with no supporting evidence, requirements with no verification, risk controls that were never tested, orphaned test data, approvals still outstanding. Every finding is traced to the exact source document and grounded in the relevant EU IVDR/MDR clause, so a reviewer sees the regulatory basis, not just a red flag. It will catch, for instance, a product claim of ±0.3 °C accuracy when the linked test only verifies ±0.5 °C, exactly the kind of mismatch that quietly fails a gate review. It's hosted in the EU, with design-control data kept in-region and GDPR built in from the start, which also matters for European technology sovereignty in regulated health. The platform is live and runs the full analysis end to end, from upload to a fully cited readiness report. Built by people who've worked in regulated MedTech R&D, for the teams who live with this problem.