Pricing that matches regulated reality

    Leida pricing follows a simple structure designed for regulated teams. Platform access covers the core workflow for compliant work, from drafting documentation with AI to reviewing, approving, and exporting evidence with a clear decision trail.

    Standards coverage and plugins can be added based on product scope and workflow needs. Go Live Sprints are available for teams that want faster setup, including integrations, governance configuration, and the first audit-ready evidence outputs from day one, built by Leida team.

    Start Free

    Platform access for small teams. Setup now, move fast, the first month is freeIncludes: Core + Bridge + Leida QMS

    0€/first month

    Runs the day-to-day loop: detect change, draft updates, package for review, approve, export.

    995€/month + 99€/user/month after free trial.

    • Evidence stays connected to day-to-day engineering work
    • Reviews and approvals produce a clean audit trail and export-ready packs
    • Jira-ready workflow: requirements and change signals can be connected to evidence
    • GitHub ready workflow
    • AI document generation
    • Review packages, versioning, approvals, controlled exports
    • Audit-ready evidence
    • EU MDR/IVDR and FDA workflow structure
  1. Covers 1 device program
    2. Sign up

    Scale

    Safety and lifecycle automation. For teams running multiple device programs and frequent releases.Includes: Core + Bridge + Leida QMS

    3499€/month

    +129€/user/month

    Everything in Platform access + standard-specific automation

    • Risk, software lifecycle, and usability evidence stays aligned with Jira and Git change
    • Repeatable release evidence packages
    • Traceability maintenance across requirements, tests, risks
    • Risk update workflows linked to training and approvals
    • CAPA automation and evidence packaging
    • Release, audit, and submission evidence packs for the device program
    • Gap detection for verification coverage and broken trace links
    • Covers up to 10 device programs
    • Usable by all platform users assigned to the program

    Scale works with your existing eQMS system: Leida generates and governs updates in Core and Bridge, then exports approved records into your current QMS.

    Leida QMS system is optional for teams that want Leida to be the system of record.

    Sign up

    Enterprise

    For high security, access control and device portfolio management.Includes: Core + Bridge + Leida QMS

    Custom pricing

    Platform at enterprise scale, plus optional QMS system of record

    • Organization-wide deployment across business units and device portfolios
    • Enterprise security controls: SSO, advanced access policies, admin governance
    • Optional Leida QMS system of record: document control, training, CAPA, audits, controlled records
    • Advanced evidence packaging for audits, submissions, and internal review boards
    • Dedicated account lead and structured rollout support
    • Security documentation package: security statement, AI use policy, DPA support
    • Unlimited scale available, scoped by environment and integration requirements
    • Standards bundles and plugins available across portfolios
    • Multiple Jira projects, multiple Git repos, multiple environments
    Sign up

    Standards - options

    Standards bundles are available to match regulatory scope. We offer a wide selection to support your medical device development. Standards can be tailor built for your business in a Go Live sprint, billed separately.

    Below some of the most popular.

    ISO 13485 Quality System Automation

    Quality system of record

    Runs quality system workflows with controlled documents, training, CAPA, and audits, keeping records current through approved updates flowing from Core and Bridge.

    ISO 14971 Risk Automation

    Coverage: Risk and safety evidence

    Automates risk management work by drafting risk updates, maintaining hazard and control traceability, and producing review-ready risk evidence packages.

    IEC 62304 Software Lifecycle Automation

    Software lifecycle evidence

    Automates software lifecycle evidence by mapping change to documentation, drafting impacted updates, and generating release-ready evidence packages.

    IEC 62366-1 Usability Engineering Automation

    Usability and human factors evidence

    Automates usability evidence by structuring usability files, linking usability to risk and requirements, and assembling review-ready documentation packages.

    ISO 27001 Security Management Automation

    Security management evidence

    Maintains an ISMS in operational form by drafting and updating security policies and controls, managing security risk assessments and treatment plans, tracking assets and access reviews, handling supplier security evidence, and producing audit-ready evidence packs for certification audits.

    FDA Software Documentation Readiness

    Submission-oriented software documentation

    Structures and packages the software documentation FDA reviewers expect to see, with clear traceability from requirements to verification and controlled change history across releases.

    Connect the tools your team already uses into one compliance system

    Jira integration

    Syncs requirements, tickets, change signals, and approvals metadata.

    GitHub Integration

    Links commits, PRs, reviews, and releases into evidence and change impact.

    Upload your existing documentation

    Imports documents, spreadsheets, and trace matrices to initialize the evidence graph, preserve version history, and generate drafted updates and gaps.

    Existing QMS Export and Sync

    Exports controlled outputs and evidence packs into an existing QMS as approved records.