Interactive forms for AEGIS regulatory documentation. Fill in the form, then download as .docx. All data stays in your browser.
Corrective and preventive action record for REJECT, ALARM, or escalated CLINICAL REVIEW events. Includes root cause analysis, corrective action plan, and regulatory notification assessment.
Verify that all AEGIS components are configured before first deployment. Covers DARM, MMM, CDM, regulatory documentation, and CAPA integration.
Complete domain configuration covering deployment context, datasets, thresholds, MLcps weights, drift detection, decision categories, gold standard, and regulatory pathway mapping.
Standalone threshold traceability table for sharing separately from the full S2 configuration. All thresholds must reference ISO 14971:2019 hazard analysis.
Reference document describing the Clinical Decision Module logic, priority-ordered decision hierarchy, PMS alarm conditions, and Python reference implementation.
Eight-step deployment workflow covering clinical context assessment through regulatory submission. Each step includes actions, deliverables, and links to relevant guide pages and templates.