Most regulatory intelligence software is merely an RSS feed or email alert scraper for FDA Federal Register notices and EU MDR MDCG guidance updates. It leaves the hardest question unanswered: "Does this matter to our exact device, which requirements must change, and how does it affect our active filings?" PMX connects external regulatory law directly to the internal product graph.
How PMX transforms passive external regulatory changes into actionable, automated design control tasks.
When a new FDA guidance or IEC 60601-1 amendment is issued, PMX evaluates the text against your product's classified intended use, device classification, biological patient contact types, and technology stack. It discards 98% of irrelevant regulatory noise, highlighting only authoritative mandates.
Unlike enterprise search that returns 400 unstructured PDF hits, PMX queries the Product Knowledge Graph to instantly identify which active SKUs, BOM configurations, or legacy software revisions incorporate the affected technology or standard.
The system drills directly into the DHF: highlighting the specific System Requirement (REQ-0184), the affected ISO 14971 Risk Analysis (RSK-0044), the invalid Verification Protocol (V-0183), and the exact submission chapter.
Demonstrating how an IEC 60601-1-11 / FDA Recognized Consensus Standard revision propagates directly to CardioSense Pro v3.8.2.
Published by IEC / Recognized by US FDA (FR Vol 91, No 44) & EU Official Journal under MDR 2017/745
"For medical electrical equipment intended for continuous patient skin contact exceeding 24 hours, the maximum allowable surface temperature of the applied part is reduced from 43.0°C to 41.0°C to eliminate sub-clinical basal cell hyperthermic degradation in immunocompromised and post-operative adult patients. Transition grace period: 180 calendar days."
A single product design control graph in PMX OS compiles simultaneously into multiple distinct national regulatory dossiers.
Full alignment with the Quality Management System Regulation (QMSR) harmonizing 21 CFR 820 with ISO 13485:2016. Direct compilation into electronic Submissions Template And Resource (eSTAR) for 510(k) premarket notifications, De Novo classifications, and PMA supplements. Enforces FDA Section 524B cybersecurity SBOM controls and 21 CFR Part 11 electronic records.
Continuous maintenance of Annex II (Technical Documentation) and Annex III (Post-Market Surveillance) files. Manages Notified Body (TÜV SÜD, BSI) substantial change notification thresholds under Article 120, EUDAMED UDI registration, and General Safety and Performance Requirements (GSPR) verification checklists.
Supports UKCA marking under the Medical Devices Regulations 2002 and the International Recognition Procedure (IRP), utilizing FDA 510(k) or EU MDR approvals for accelerated access to NHS procurement pathways while maintaining Northern Ireland dual-protocol compliance.
Complies with the Medical Device Rules 2017 (MDR 2017) under the Central Drugs Standard Control Organization. Automatically structures Device Master Files (DMF) and Plant Master Files (PMF) for Sugam portal submissions, Form MD-14 import licenses, and Central Licensing Approving Authority (CLAA) manufacturing audits.
Governed by the Medical Devices Regulations (SOR/98-282). Enforces Medical Device Single Audit Program (MDSAP) QMS prerequisites for Class II, III, and IV Medical Device Licences (MDL), linking clinical trial evidence to Canadian labelling bilingual requirements.
Aligns design history records with the Therapeutic Goods (Medical Devices) Regulations 2002. Generates Essential Principles Conformity Assessment checklists and streamlines Australian Register of Therapeutic Goods (ARTG) inclusion via European CE mark or FDA predicate recognition.
Governed by the Pharmaceuticals and Medical Devices Agency under the PMD Act. Structures Foreign Manufacturer Accreditation (FMA) records, maps Japanese Medical Device Nomenclature (JMDN) codes, and complies with MHLW Ministerial Ordinance No. 169 (Japanese QMS standard).
Eliminate the duplicate work of authoring separate 510(k), EU MDR, and CDSCO binders. Compile compliant technical dossiers directly from your living product knowledge graph.