Demonstrable System Depth

This page provides evidence of capability without relying on testimonials or client disclosures.
All examples reflect real QMS architectural structures: document control frameworks, training systems, CAPA workflows, audit trails, PMS routes, risk management files, supplier lifecycle structures, validation pathways and controlled M365/SharePoint environments.
The systems shown here are consistent with ISO 13485:2016 Clause 4–8 requirements, ISO 14971 risk integration, MDR/IVDR documentation, and FDA QMSR expectations.

What We Consistently Deliver

  • Regulator-Aligned QMS

    Structured QMS architectures designed to satisfy ISO 13485, ISO 14971, MDR Annex II/III, IVDR documentation, FDA Design Control and QMSR alignment.

  • End-to-End Validation Packs

    URS, Risk Assessments, IQ/OQ/PQ, Trace Matrices, Validation Reports, Change Control and Periodic Review frameworks developed to regulatory standard.

  • Technical Documentation

    GSPR mapping, device description packs, CER/PER structures, PMS/PMCF frameworks, UDI/traceability systems and Design History File architecture.
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System Architecture Depth

We design complete QMS frameworks with controlled document libraries, hierarchical folder structures, content types, metadata governance, retention rules and automated change control workflows.
All structures comply with ISO 13485:2016 documentation requirements (4.2.4, 4.2.5) and integrate directly with training, CAPA, NCR, audit and PMS processes.

Operational Workflows & Controlled Processes

Controlled process flows demonstrate competence beyond documentation—mapping how training, CAPA, internal audits, calibration, supplier management and PMS functions operate under regulatory conditions.
Automated workflows include approval routing, update notifications, competence reassignment triggers, and controlled retention.

Already Implemented System (Screenshots)

Regulatory Authority Alignment

ISO 13485:2016:
All QMS structures—including document control, training, audits, CAPA, production controls and PMS—are mapped directly to the standard.
Evidence: controlled libraries, training matrices, change control protocols and record retention mapping.

ISO 14971:
Risk processes include hazard identification sheets, risk matrices, hazardous situation mapping, probability/severity tables, risk-control allocation and RMF integration.

EU MDR / IVDR:
Systems support complete Annex II/III documentation, PMS/PMCF, GSPR mapping, CER/PER structures and UDI/traceability frameworks.

FDA QMSR / 21 CFR 820:
Design control templates, DHF/DMR/DHR folders, verification/validation structures and complaint handling logs follow FDA expectations.

Structured Delivery Method

1. Discovery
Jurisdiction, device classification, documentation maturity, risk profiles and production workflows are assessed.

2. QMS Architecture Blueprint
Document control, training, audit, CAPA, PMS and risk pathways are designed as a unified system, not isolated templates.

3. System Build
Libraries, content types, metadata, permissions, templates, registers, SOP suites and workflows are deployed.

4. Validation
URS → RA → IQ → OQ → PQ → Summary
Alignment with ISO 13485 clause 4.1.6 and global regulatory expectations.

5. Training & Handover
Competence matrix, LMS workflows, structured training packs and regulatory onboarding.

6. Post-Deployment Governance
Ongoing updates, PMS evolution, documentation improvements, audit preparation and regulatory maintenance.