Tailored for medical device, diagnostic, and life-critical engineering organizations navigating hardware complexity and stringent regulatory oversight.
For innovative engineering teams exploring connected product intelligence, semantic requirement modeling, and foundational traceability.
For growing regulated medical product teams scaling development, verification, multi-market submissions, and active clinical trials.
For multi-product organizations with complex regulatory portfolios, proprietary ERP/PLM integrations, and sovereign data isolation needs.
A rigorous evaluation of capabilities across 11 core functional engineering domains.
| Functional Domain & Capability | Explorer | Growth | Enterprise |
|---|---|---|---|
| 1. Product Modeling & Knowledge Graph Architecture | |||
| Semantic Node & Edge Graph Modeling | Up to 25k Nodes | Up to 250k Nodes | Unlimited High-Scale |
| Active Product Portfolios | 1 | Up to 5 | Unlimited |
| Custom Ontological Entity Definitions | Standard Only | Configurable | Fully Custom Extensible |
| 2. Hardware & Mechanical Traceability (CAD / BOM / PLM) | |||
| Hierarchical Bill of Materials (BOM) Ingestion | CSV / XML | Automated PLM Sync | Real-Time Native Connectors |
| CAD Dimensional Change Tracking | — | Supported | Advanced Parametric Diff |
| 3. Software & Firmware Verification (IEC 62304) | |||
| Git Repository Linkage & Pull Request Traceability | Standard | Multi-Repository | Enterprise Monorepo / Distributed |
| IEC 62304 Software Safety Class Mapping (Class A, B, C) | Supported | Automated Segregation | Automated Verification Pipelines |
| 4. Regulatory Standards & Statutory Ontology Mapping | |||
| FDA 21 CFR Part 820 & QMSR Alignment | Core Clauses | Comprehensive | Comprehensive + Multi-Jurisdiction |
| EU MDR 2017/745 Annex I GSPR Matrix | — | Included | Automated Annex Concordance |
| 5. Risk Management & Hazard Analysis (ISO 14971) | |||
| ISO 14971 Risk Matrix & Mitigation Tracing | Manual Linkage | Dynamic Graph Linkage | Closed-Loop Automated Hazard Mesh |
| Design & Process FMEA Generation | Exportable | Bidirectional Live FMEA | Enterprise Portfolio-Wide FMEA |
| 6. Change Impact Simulation & Ripple Analytics | |||
| Upstream / Downstream Ripple Evaluation | 1-Hop Traversal | N-Hop Deep Traversal | Full Graph Digital Twin Simulation |
| Pre-Commit Engineering Change Order (ECO) Preview | — | Supported | Multi-Variant Branch Simulation |
| 7. Evidentiary AI & Human-in-the-Loop Copilot | |||
| Grounded Evidence Citation Engine | — | Active | Active + Custom Validation Rules |
| Human Review & Affirmative Sign-off Workflows | Basic | Multi-Stage Review | Enterprise Governance Hierarchies |
| 8. Audit Trail & Cryptographic Provenance | |||
| Append-Only Event Ledger with Actor Signatures | Standard Log | SHA-256 Hashed Stream | Merklized Cryptographic Proofs |
| Instant Regulatory Audit Dossier Export | PDF / CSV | Interactive Electronic DHF | Continuous Auditor Portal Access |
| 9. Post-Market Surveillance & Signal Ingestion | |||
| Adverse Event & Customer Complaint Ingestion | — | Periodic Batch Feed | Real-Time Clinical Telemetry Feed |
| Post-Market Clinical Follow-up (PMCF) Risk Feedback | — | Automated Flagging | Closed-Loop Risk Recalibration |
| 10. Security, Identity & Data Sovereignty | |||
| Data Enclave & Deployment Model | Multi-Tenant Cloud | Isolated Tenant Enclave | Dedicated VPC / Sovereign On-Prem |
| Single Sign-On (SSO) & Encryption Keys | Email / MFA | SAML 2.0 / OIDC | SAML + CMEK Key Ownership |
| 11. Dedicated Support, Advisory & Onboarding | |||
| Technical Onboarding & Migration Architecture | Documentation & Guides | Guided Technical Workshop | Dedicated Solutions Architect |
| Support Channel & Response Times | Standard Ticket Support | Priority Email & Slack Sync | 24/7 Priority Emergency SLA |
Licensing is structured on an enterprise basis scaled by active product portfolios, graph scale, and deployment model (cloud enclave vs. sovereign virtual private cloud). We do not charge per-seat penalties that discourage engineering cross-collaboration between hardware, software, and regulatory teams. Contact our enterprise sales team at sales@theprimexia.com for a tailored consultation.
The customer retains 100% unconditional ownership of all proprietary data, design files, code repositories, risk matrices, and regulatory submissions. ThePriMexia operates strictly as a data processor. Your intellectual property is never commingled, shared, or utilized to train external or multi-tenant machine learning models.
Yes. Enterprise tier deployments support sovereign VPC instances within your organization's cloud tenancy (AWS, Azure, Google Cloud) or isolated private cloud environments meeting stringent national defense or life-critical regulatory criteria.