FDA and MDR compliance for modern medical device teams
Continuous compliance for medical device teams that ship at speed and scale. Leida connects engineering, product development and quality evidence into one system of record for decisions. When code, requirements or risk changes, Leida updates what compliance needs next and routes it for approval.
Compliance that runs inside product development
Connect scattered change signals to a controlled evidence chain, draft the required updates, route approvals with a decision trail, and produce export-ready evidence packs for EU and FDA workflows.
Agentic AI for regulated product development
Operating model that stays current as the product evolves.
Audit-ready exports
Evidence packs on demand
Versioned approvals
Every change leaves a decision trail
1 evidence chain
Intent → requirements → risk → verification → records
Jira + Git
Change signals connected to evidence
Regulatory AI that turns complexity into clarity
A single place to understand requirements, train the team, and draft the evidence, with outputs that stay reviewable and export-ready.
Leida Regulatory AI is a practical copilot for regulated teams. It can be used as a chat interface to make sense of standards and guidance in plain language, translate regulatory requirements into concrete tasks, and answer "what does this mean for our product" with traceable references.
It also supports training and education inside the organization by generating role-specific explanations, checklists, and learning material that reflect the actual device program and the evidence trail. When documentation work is needed, Leida Regulatory AI drafts and updates the required content in the team's format, then packages it for controlled review and approval so the output stays audit-ready.