Modern MedTech ships continuously. With new tools.
The hard part of regulated software is not doing the work. The hard part is keeping requirements, risk, verification, and documentation aligned as the product evolves.
Build regulations and standards into product development.
Continuous compliance is a workflow.
Connect Change to evidence
Link requirements, tickets, code, tests and releases into the same evidence chain.
Maintain a single evidence trail
Single source of truth where requirements, risks, controls, verification, and records stay linked so impact remains visible.
Turn updates into controlled packages
Make drafting, review, approval, and export happen in one governed flow and every change leaves a decision trail.
Keep the system of record stable
Let your existing eQMS remain the archive while upstream evidence maintenance and packaging stays continuous, or use Leida QMS.
What improves immediately
Releases move forward with fewer late surprises.
Impact stays visible throughout the change.
Evidence stays aligned across risk, requirements, verification, and documentation, even as the product evolves.
Audits become a controlled export and a clear narrative, rather than a reconstruction project.
The new standard in regulated work is to build regulation into the product development
Compliance will always require judgment, ownership, and sign-off. What changes is the operating model: evidence stays continuously current as work evolves, decisions are captured at the moment they are made, and audits run from a system that reflects reality rather than reconstruction.
Leida Core - compliance intelligence
Leida Core detects product change and translates it into regulatory actions. It builds and maintains the evidence graph linking intent, requirements, risks, tests, and records, then generates the required updates.
It uses AI to draft and update the impacted documentation, propose trace links and risk control changes, and assemble review-ready evidence packages for bridge and approval.
Leida Compliance Bridge
Leida Bridge is the controlled workspace where changes become compliant updates. It is where AI-drafted document edits, trace updates, and risk changes are gathered into versioned bundles and routed through the right reviews.
Bridge keeps drafts separate from approved records, captures decisions and signatures, and produces clean, audit-ready evidence packages before anything is promoted into the QMS or exported to an existing QMS.