For VP of QA and systems engineers. Compliance artifacts generated automatically as tickets move.
Manual documentation overhead across Jira, scripts, and spreadsheets.
Fragmented tools miss regulatory deadlines, delaying releases.
Jira + ALM + custom scripts + plugins that break under audit.
Assembling trace matrices and evidence, manually, every cycle.
Defect states enforced per medical device software lifecycle.
CoreEvery transition logged, timestamped, and export-ready.
CoreLink defects directly to procedures, work instructions, forms.
CoreBuilt-in severity and probability assessment per IEC 62304.
CoreBidirectional sync with existing dev tools, no plugins.
CoreFDA, ISO 13485, and IEC 62304 rules enforced natively.
RoadmapSelect FDA, ISO 13485, or IEC 62304. Medigate maps rules to your workflow.
Defects transition through states; compliance artifacts generate automatically.
Export complete audit trails and trace matrices with one click.
Join the waitlist. Pilot with your team, then scale.
HIPAA compliant · HITECH ready · Clinical outcomes data
Defect states are predefined to match the standard. Each transition triggers the required documentation automatically, so no manual step can be skipped.
Yes. Bidirectional sync works out of the box, no plugins or custom scripts. Defects and their compliance artifacts stay in sync.
Every state change, timestamp, user, and linked QMS document. Exportable as a complete trace matrix for FDA or ISO audits.
Yes. Electronic signatures and audit trails meet Part 11 requirements, with full audit history on every record.
Most teams configure standards and sync within a day. Full rollout with QMS document linking typically takes under a week.
For VP of QA and systems engineers. Compliance artifacts generated automatically as tickets move.
Manual documentation overhead across Jira, scripts, and spreadsheets.
Fragmented tools miss regulatory deadlines, delaying releases.
Jira + ALM + custom scripts + plugins that break under audit.
Assembling trace matrices and evidence, manually, every cycle.
Defect states enforced per medical device software lifecycle.
CoreEvery transition logged, timestamped, and export-ready.
CoreLink defects directly to procedures, work instructions, forms.
CoreBuilt-in severity and probability assessment per IEC 62304.
CoreBidirectional sync with existing dev tools, no plugins.
CoreFDA, ISO 13485, and IEC 62304 rules enforced natively.
RoadmapSelect FDA, ISO 13485, or IEC 62304. Medigate maps rules to your workflow.
Defects transition through states; compliance artifacts generate automatically.
Export complete audit trails and trace matrices with one click.
Join the waitlist. Pilot with your team, then scale.
HIPAA compliant · HITECH ready · Clinical outcomes data
Defect states are predefined to match the standard. Each transition triggers the required documentation automatically, so no manual step can be skipped.
Yes. Bidirectional sync works out of the box, no plugins or custom scripts. Defects and their compliance artifacts stay in sync.
Every state change, timestamp, user, and linked QMS document. Exportable as a complete trace matrix for FDA or ISO audits.
Yes. Electronic signatures and audit trails meet Part 11 requirements, with full audit history on every record.
Most teams configure standards and sync within a day. Full rollout with QMS document linking typically takes under a week.