Medical products are built through thousands of connected decisions across hardware, software, clinical risk, and regulatory standards. When one changes, everything downstream moves. PMX OS is the intelligence layer that models these connections in real time—so your team can move fast without breaking compliance, safety, or quality.
Medical devices, active implants, IVDs, and Software as a Medical Device (SaMD) are inherently interconnected systems. Yet the tools used to create and regulate them are historically isolated into brittle, human-bridged silos.
Requirements live in modern ALM suites. Risks hide inside static spreadsheets. Mechanical CAD resides in PDM vaults, and firmware commits trigger on GitHub. When an engineer adjusts a thermistor resistance threshold or changes a bus clock frequency, there is no automatic signal sent to the ISO 14971 Risk Analysis file.
Before an FDA 510(k), De Novo, or EU MDR submission, teams freeze development for 3 to 6 months to construct traceability matrices by hand. Cross-functional leads spend hundreds of hours manually comparing line-item numbers across PDF exports to prove verification coverage to notified body auditors.
When component obsolescence forces a sensor replacement (such as S-18 to S-22), engineers assume it is a minor drop-in change. Because no live dependency graph exists, nobody realizes the new component's thermal dissipation profile invalidates a 36-hour clinical skin safety protocol until validation fails on the bench.
How regulated product development evolves from document-based reconciliation to continuous intelligence.
Information is trapped in static documents. Changes require manual cross-checking across siloed departments, leading to late discovery of compliance gaps.
The product is a living semantic graph. Every engineering intent, hazard mitigation, test case, and regulatory clause is interconnected with instant impact analysis.
In PMX OS, medical products are not collections of disjointed files. They are living graphs of 10 interdependent operational domains. An alteration in any single node propagates contextually throughout the entire lifecycle.
Clinical purpose, patient demographics, intended environment, and primary usability goals.
Mechanical geometry, schematic electrical layouts, hardware architecture, and firmware logic.
Foreseeable sequences of events leading to thermal, electrical, biological, or operational harms.
Inherently safe design features, protective interlocks, firmware limits, and safety labeling.
Empirical bench tests, EMC sweeps, environmental stress tests, and automated test fixtures.
Calibrated sensor logs, statistical sample size rationales, lab reports, and raw telemetry.
FDA 510(k) predicates, EU MDR Annex II technical files, IEC 60601-1, and ISO 13485 clauses.
Tier-1/2 vendor qualification, lot inspection records, certificates of conformance, and PCNs.
Embedded C/C++, containerized SaMD microservices, cryptographic hashes, and CVE mitigations.
Real-world hospital telemetry, service logs, vigilance reporting, and post-market safety trends.
Instead of storing requirements in Jira, risks in Excel, and verification protocols in Word, PMX OS unifies your entire product definition into an ontological knowledge graph.
implements, controls_hazard, verified_by, complies_with, and sourced_from.
| Node ID | Domain | Relationship | Connected Target |
|---|---|---|---|
S-18 |
Hardware | implements | REQ-0184: Thermal Limit |
REQ-0184 |
Requirement | controls | RSK-0044: Thermal Injury |
RSK-0044 |
Risk | verified by | V-0183: 36h Thermal Bench |
V-0183 |
Verification | submitted in | FDA 510(k) K240982 |
S-18 |
Supplier | sourced from | SUP-Y (MicroSens Corp) |
Simulate a real-world MedTech engineering change: replacing analog temperature sensor S-18 with digital sensor S-22 in the CardioSense Pro wearable telemetry monitor.
Replacing a passive sensor is rarely just an engineering task. In PMX OS, the impact engine automatically identifies and scopes all 23 affected objects across 8 disciplines before a single solder joint is modified:
In life sciences and regulated medical products, generative AI cannot be an ungrounded black box. Every suggestion made by PMX OS is backed by a verifiable chain of custody.
The AI recommends executing test protocol V-0183 under the S-22 thermal profile prior to engineering change sign-off.
Evidence Citation: "Surface temperature of medical electrical equipment in contact with intact adult human skin for >10 minutes shall not exceed 41.0°C."
Finite element analysis demonstrates localized PCB junction heat dissipation of 41.3°C under worst-case 100Hz continuous telemetry transmission.
The recommendation cannot take effect autonomously. It routes to designated qualified humans with multi-factor biometric signatures and timestamped audit logs.
Rather than a generic chatbot, PMX OS deploys 9 dedicated, evidence-grounded AI copilots designed around international medtech standards.
Monitors CAD, electrical schematics, and systems specifications. Flags cross-subsystem interface incompatibilities, power budget overruns, and mechanical tolerance stack-ups.
Traverses hazard sequence trees in real time. Analyzes single-fault conditions, evaluates risk mitigation effectiveness, and calculates residual risk matrices according to ISO 14971:2019.
Evaluates substantial equivalence against FDA predicate databases. Dynamically determines whether an ECO mandates a new 510(k), Special 510(k), or EU MDR Significant Change filing.
Validates requirement-to-protocol test coverage. Identifies stale test protocols after firmware revisions, evaluates statistical power, and drafts delta verification test suites.
Links clinical claims and endpoints directly to empirical clinical trial data. Scans medical literature for state-of-the-art equivalence and maintains continuous clinical evaluation reports (CER).
Monitors national vulnerability databases (NVD) against device Software Bill of Materials (SBOM). Evaluates exploitability scores (CVSS) and enforces FDA premarket cybersecurity guidance.
Ensures Device Master Record (DMR) consistency with design freeze. Verifies IQ/OQ/PQ process validation parameters, supplier quality limits, and work instruction alignments.
Monitors hospital customer complaints, MDR adverse events, and telemetry anomalies. Automatically calculates complaint trending spikes and triggers proactive CAPA investigations.
Oversees on-device machine learning models (such as RespiraAI v4.2). Enforces Predetermined Change Control Plans (PCCP), data drift monitoring, and EU AI Act conformity documentation.
PMX OS is not just a pre-market design tool or a post-market QMS. It operates as the persistent intelligence thread from initial clinical concept to continuous commercial improvement.
Traditional QMS systems are reactive: they wait for customer complaints or failed audits before initiating a CAPA. PMX OS utilizes graph correlation to predict systemic failures before they reach patients.
Based on correlated supplier lot drift, firmware duty cycle, and 3 subtle post-market complaint signals.
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In aerospace and industrial engineering, a "digital twin" is usually a 3D geometric mesh or thermal physics simulation. In regulated healthcare, that is only 10% of the picture.
The PMX Digital Twin models the total regulatory, architectural, and operational state of the product. It captures what you intended to build (requirements), how it was built (BOM & code), why it is safe (hazards & mitigations), how it was proven (bench & clinical data), and what global health authorities approved.
Explore Regulatory Digital Twin Capabilities →From fragmented document systems to autonomous, continuous regulatory orchestration.
Unifying requirements, risks, verification protocols, and regulatory filings into an ontological graph. Instant blast radius computation for engineering changes.
Specialized domain agents continuously monitoring git commits, CAD check-ins, and supplier PCNs, automatically generating delta verification protocols.
Real-world evidence (RWE) directly closes the feedback loop, updating hazard probabilities in real time and notifying notified bodies of dynamic safety profiles.
Regulators query the living digital twin directly via secure cryptographic APIs, replacing batch 510(k) and MDR document submissions with continuous compliance streams.
AI-driven medical devices autonomously adapt operating parameters within approved Predetermined Change Control Plans (PCCP) with mathematically proven safety invariants.
Built for the complex cross-disciplinary teams required to bring regulated devices to life.
Hardware, firmware, and software engineers who need to innovate fast without fear of invisible regulatory tripwires. Know the exact compliance blast radius before merging code or issuing an ECO.
Engineering Solutions →RA directors and specialists tired of manual predicate comparisons and 500-page dossier assembly. Keep technical documentation synchronized with live engineering in real time.
Regulatory Solutions →QA leads responsible for ISO 13485, 21 CFR 820, and continuous audit readiness. Eliminate spreadsheet trace matrices and conduct instant root-cause analysis on deviations.
Quality Solutions →Medical directors and clinical scientists managing trial protocols and clinical evaluation reports. Connect clinical endpoints directly to risk mitigations and device performance specs.
Clinical Solutions →Product security officers managing SBOMs, threat models, and vulnerability remediation across IoT medical hardware and cloud telemetry backends.
Security Solutions →Process engineers and supply chain directors handling component shortages and vendor changes. Determine instantly whether an alternate supplier requires re-validation.
Manufacturing Solutions →Maintain executive visibility across the entire product portfolio. Track submission readiness velocity, eliminate audit panic, protect corporate valuation from catastrophic product recalls, and cut cycle times by months.
Medical innovation saves lives, but disconnected compliance silos throttle progress. By transforming static records into a living product knowledge graph, PMX OS empowers regulated teams to engineer with clarity, velocity, and unassailable confidence.