Medical device development fails when engineering speed clashes with regulatory inertia. PMX OS replaces disconnected spreadsheets and siloed document stores with a living knowledge graph that maps every design commit directly to clinical hazards and global clearance files.
Choose your operational focus below to inspect tailored workflows, real-world data structures, and governance outcomes.
Accelerate prototype cycles without generating insurmountable compliance debt. Instant DHF compilation for fractional regulatory teams.
Orchestrate multi-site, multi-country submissions across disparate legacy PLMs, SAP instances, and Notified Bodies without disruption.
Govern continuous algorithmic iteration, FDA Predetermined Change Control Plans (PCCP), telemetry drift, and EU AI Act conformity.
Transform passive dossier writing into continuous regulatory intelligence. Automated predicate mapping and Letter-to-File decision trees.
Eliminate late-stage verification surprises. Bring risk mitigations and safety standards directly into Git commits and CAD releases.
Continuous ISO 13485 & FDA QMSR traceability. Isolate CAPA blast radius across the graph in seconds rather than weeks of file forensics.
Early-stage medical device companies operate under intense capital velocity. Founding engineers focus on getting benchtop prototypes working, while fractional regulatory consultants struggle to reconstruct design history from fragmented Slack threads, CAD files, and Google Drive folders.
PMX OS provides startups with an out-of-the-box knowledge graph that automatically ingests commits, CAD metadata, and test benches. External consultants log into a federated workspace with full visibility into verified relationships, slashing administrative overhead and maintaining submission-ready DHF from commit one.
During the early bench phase of CardioSense Pro v3.8.2, the hardware engineer substituted thermistor component S-18 with alternative sensor S-22 due to lead-time shortages.
Instead of discovering this discrepancy during pre-submission freeze, PMX OS flagged that S-22 had an unverified dissipation curve under requirement REQ-0184. The startup re-ran verification test V-0183 immediately, preserving their 510(k) schedule.
Continuous audit readiness without manual document reconciliation; seamless consultant integration with immutable cryptographic sign-offs; eliminated risk of pre-submission redesign surprises.
Multi-billion dollar MedTech enterprises manage thousands of active SKUs across dozens of geographic jurisdictions. When a tier-2 supplier issues an end-of-life notice or alters a raw material specification, tracing the blast radius across hundreds of global clearances is paralyzing.
PMX OS deploys a non-destructive knowledge layer over existing PLM, ERP, and QMS databases. It constructs an enterprise-wide dependency graph that links raw component part numbers directly to finished good device identifiers (UDI), technical files, and regional clearance certificates.
Change CHG-1024 impacts component S-18 across the CardioSense Pro product tree.
The PMX OS Change Simulator instantly maps propagation: 1 physical assembly, 1 thermal safety requirement (REQ-0184), 1 biological hazard (RSK-0044), US clearance K221840, and EU MDR CE Certificate CE-682914. Global regulatory heads receive automated country-specific filing guidance simultaneously.
Elimination of undocumented cross-border regulatory non-compliance; deterministic visibility into component obsolescence blast radius; unified audit defensibility across global notified bodies without multi-month manual data consolidation.
Machine learning-enabled medical devices (Software as a Medical Device - SaMD) violate the traditional "frozen waterfall" assumption of medical device regulations. Continuous re-training, hyperparameter optimization, and real-world clinical drift require rigorous algorithmic change control protocols.
PMX OS treats ML models, training datasets, annotation schemas, and inference pipelines as first-class nodes in the product knowledge graph. It evaluates every model candidate against FDA PCCP boundaries, automatically certifying whether retraining falls under internal change control or mandates a new 510(k).
CardioSense Pro includes an on-device arrhythmia classification network (ALG-ECG-02).
When the data engineering team retrained the model using an expanded European patient cohort, PMX OS automatically validated specificity against authorized PCCP Protocol 3. It verified that false positive rates remained <0.8% under stress conditions, logging cryptographically signed verification evidence into the DHF without regulatory delay.
Deterministic verification of PCCP protocol adherence; complete data lineage from training pixel/signal to model commit; automated alignment with EU AI Act high-risk risk management and post-market monitoring duties.
Regulatory Affairs professionals are traditionally positioned as reactive gatekeepers, forced to assemble monolithic submission binders months after engineering changes have been finalized. PMX OS transitions RA into a continuous, data-driven intelligence function.
PMX OS codifies FDA 510(k) modification guidance and EU MDR MDCG guidance into deterministic graph traversal rules. Any proposed design change is instantly evaluated against predicate characteristics and safety boundaries, generating automated regulatory pathway recommendations.
Evaluating Change CHG-1024 (transducer swap from S-18 to S-22).
The PMX OS Regulatory Engine evaluates the thermal delta against FDA Guidance "Deciding When to Submit a 510(k) for a Change to an Existing Device". Because the operational surface temperature remains constrained under 41.0°C (IEC 60601-1-11) and verification test V-0183 passes, PMX OS auto-compiles an auditable Letter-to-File package, avoiding an unnecessary 510(k) submission.
Defensible, automated Letter-to-File justifications with complete supporting evidence links; continuous synchronization with predicate technological characteristics; eliminated late-stage regulatory filing discoveries.
Engineers want to build high-performance hardware, embedded firmware, and modern software. They dread traditional compliance workflows that force them into clunky, slow eQMS portals to manually fill out 20-page engineering change order (ECO) justification forms.
PMX OS integrates directly into developer toolchains (GitHub, GitLab, Jira, Altium, SolidWorks). When an engineer creates a pull request or commits a CAD revision, the Change Simulator instantly calculates the blast radius, showing affected requirements, risks, and test protocols right in their IDE or PR.
Hardware engineering initiated change CHG-1024 in the PMX Sandbox to evaluate substituting transducer S-18 with S-22.
Before placing a purchase order, PMX OS showed that S-22 dissipation impacts requirement REQ-0184 and hazard RSK-0044. The simulator guided the engineer to execute bench test protocol V-0183 first, confirming thermal compliance before committing production tooling.
Eliminated verification surprises at formal test lab phase; frictionless developer experience with automatic requirement linkage; zero double-entry between Git/Jira and compliance documentation.
Quality managers bear the legal and regulatory burden of proving total design control under ISO 13485:2016 and FDA 21 CFR Part 820 (QMSR). Yet most QA teams are forced to rely on manually maintained Excel traceability matrices that fall out of sync within hours of being signed.
PMX OS replaces static trace matrices with an active, bidirectional knowledge graph. Every user need, functional specification, hardware component, risk analysis node, and verification protocol is linked via typed semantic edges. Any gap or broken trace triggers an instant system alert.
Quality links complaint investigation CAPA-2026-088 directly to CardioSense Pro v3.8.2.
By querying the PMX Knowledge Graph, QA immediately isolates the blast radius: Transducer S-18, Requirement REQ-0184 (skin contact ≤41.0°C), and Hazard RSK-0044. The system displays verified test protocol V-0183 and confirms that the replacement transducer S-22 (CHG-1024) safely remedies the thermal anomaly.
Deterministic CAPA root-cause scoping within minutes; continuous zero-gap ISO 13485 design traceability; instant push-button audit export for FDA 21 CFR Part 820 and Notified Body unannounced inspections.
Whether you are taking a breakthrough device through its first FDA 510(k) or managing an enterprise portfolio across 40 global markets, PMX OS delivers verifiable lifecycle clarity without disrupting your engineering momentum.