23 Modules. One Platform. Zero Compliance Gaps.

Real-time compliance metrics, module health, and open action items across all QMS modules.

• Live KPI widgets — CAPA status, audit readiness, DHF completeness
• Cross-module risk heatmap with overdue action alerts
• Management review data export for ISO 13485 §5.6

Customer relationship management tailored for medical device sales — distributors, hospitals, and procurement teams.

• Lead pipeline with tender and RFQ stage automation
• Regulatory inquiry tracking and complaint logging
• Customer document vault linked to post-market surveillance

Product development project management with regulatory milestone tracking and DHF linkage.

• Gate review milestones with QMS document deliverable checklist
• DHF linkage — project closes only when DHF is complete
• Cross-team assignment with responsible party tracking

Complete device lifecycle documentation — design inputs, outputs, verification, validation — with e-signatures and full traceability.

• Device lifecycle tracking from design input to design transfer
• DHF completeness score with gap identification
• E-signature locking on section completion

Manufacturing travellers and device build history records with step-by-step sign-off workflows.

• Build record creation with production stage sign-off
• In-process inspection records with pass/fail capture
• Lot traceability linked to shipment records

Device shipment records, lot tracking, and distribution documentation from factory to customer.

• Lot/batch tracking with UDI fields for EU MDR readiness
• Distribution records with e-signature on device release
• Recall-ready lot search across all destinations and time periods

Controlled document management with versioning, multi-level approval workflows, and 21 CFR Part 11 e-signatures.

• Version control with Draft → Review → Approved → Superseded lifecycle
• Multi-level approval with role-based signature authority matrix
• CDSCO watermarks on document headers — inspection-ready

Document Change Orders — manage, track, and close changes to controlled documents with impact assessment.

• Change impact assessment with linked document tracking
• Expedited and standard approval workflow templates
• Closure verification with effectiveness check

ISO 14971-aligned risk register with severity/probability matrix, FMEA worksheets, and residual risk sign-off.

• 5×5 risk matrix with severity, probability, and detectability scoring
• FMEA worksheets with failure mode and effect analysis
• Residual risk acceptability review with e-signature requirement

Corrective and Preventive Actions tracked from detection to verified closure. Non-Conformance Records with root cause and disposition.

• 8D methodology — root cause through effectiveness verification
• Automatic CAPA creation from audit findings, NCRs, and complaints
• CAPA cannot close without effectiveness verification sign-off

Internal and external audit management, finding tracking, and CAPA linkage — CDSCO Form 34B inspection-ready.

• Audit programme scheduling with pre-loaded CDSCO and ISO 13485 checklists
• Finding categorisation (Minor/Major/Critical) and CAPA auto-linkage
• Inspector-ready evidence pack assembled in one click

Organisation-wide QMS clause coverage dashboard — see your compliance posture against all four frameworks at a glance.

• Clause-by-clause compliance status with evidence linkage
• Gap identification with prioritised remediation list
• Management review data export — trend charts and KPI summaries

Approved supplier register, supplier audits, and critical supplier qualification — with performance monitoring.

• Approved supplier register with evaluation criteria and scoring
• Supplier audit scheduling with 30-day requalification alerts
• Performance monitoring dashboard with trend analysis

Employee training records, competency tracking, and role-based training plans. First thing CDSCO inspectors ask for.

• Role-based training plan assignment with completion tracking
• Competency verification with certificate upload
• Expiry reminders and mandatory training gates before system access

Org structure, department management, and cross-functional team configuration with responsibility matrix.

• Department hierarchy with cross-module team assignment
• Responsibility matrix for QMS functions and process owners
• Org chart linkage to document approval authority

Role-based access control, user provisioning, MFA enforcement, and module-level permissions.

• 6 role types with granular module-level permissions
• Mandatory MFA for all users — Cognito-managed identity
• User audit trail — login, action, and offboarding records

Generate SOPs, conduct gap analyses, and get regulatory guidance powered by AI trained on CDSCO and ISO 13485.

• SOP generation — describe the process, get a complete compliant draft
• Regulatory gap analysis against CDSCO, ISO 13485, or 21 CFR Part 11
• Q&A on CDSCO/ISO clauses with sourced answers

Automated alerts for CAPA due dates, audit schedules, document reviews, training expiry, and supplier requalification.

• Email + in-app alerts for every time-sensitive QMS action
• Configurable escalation — overdue items notify manager automatically
• Supplier qualification expiry alerts 30 days in advance

Platform-level administration — organisation management, module toggles, and cross-organisation audit logs.

• Multi-organisation management for enterprise deployments
• Module access control and tier configuration
• Platform-wide audit trail — every admin action logged

Real-time stock tracking for raw materials, components, and finished goods — with full lot traceability and reorder alerts.

• Incoming goods receipt with supplier lot number and CoC linkage
• Component traceability to finished device — supports recall investigations
• Minimum stock level alerts and reorder workflow integration

Supplier purchase order creation, approval workflows, and delivery tracking — linked to the Approved Supplier Register and Inventory module.

• PO creation with automatic approved-supplier validation
• Multi-level approval workflow with QA review gate for critical components
• Delivery confirmation with GRN generation and inventory auto-update

Customer invoice generation linked to shipment records — with device lot numbers, UDI fields, and distribution audit trail for post-market traceability.

• Invoice creation auto-populated from Shipment Tracking records
• Lot number and UDI fields on every invoice for regulatory traceability
• Invoice history searchable by customer, device, or lot number for recall support

End-to-end project execution with milestone tracking, resource allocation, and real-time budget monitoring — purpose-built for regulated medical device product development.

• Project timelines with gate review milestones and regulatory deliverable checklists
• Budget planning and real-time cost tracking with variance alerts
• Resource allocation across projects with workload visibility
• DHF and CAPA linkage — project cannot close with open quality actions
• Management reporting: budget vs. actuals, schedule adherence, risk status