The era of superficial predicate equivalence is over. Under EU MDR Article 61 and modern FDA Digital Health guidance, every marketing claim, diagnostic indication, and patient safety assertion must be anchored in continuous empirical clinical data. PMX Clinical Intelligence links intended use statements directly to prospective trial cohorts, statistical confidence bounds, and living Clinical Evaluation Reports (CER).
Why modern medical device companies cannot rely on static literature reviews and disconnected clinical binders.
Under the old European MDD, manufacturers frequently claimed equivalence to competitor devices without direct access to technical files. Under EU MDR Annex XIV Section 3, you must prove biological, technical, and clinical equivalence concurrently, with full contractually guaranteed data access to the equivalent device's technical dossier.
Both the FDA and Notified Bodies require continuous Post-Market Clinical Follow-up (PMCF) to demonstrate that pre-market safety assumptions remain valid across heterogeneous real-world patient demographics, comorbidities, and extended continuous wear cycles.
A 600-page static Clinical Evaluation Report in Word freezes in time the day it is printed. When software algorithms evolve (e.g., RespiraAI v4.2 update), a static CER fails to reflect the updated algorithmic sensitivity, creating substantial regulatory non-compliance.
Observe the formal ontological lineage from high-level clinical claims through statistical trials to regulatory filings.
Empirical evidence validating CardioSense Pro v3.8.2 continuous monitoring safety and AI algorithmic precision.
Conducted under ISO 14155:2020 (Good Clinical Practice for Medical Devices)
Select a clinical claim below to trace its empirical backing through clinical trials, endpoints, and submission sections.
CLN-088 (CS-088) across 240 post-operative cardiac patients, comparing RespiraAI v4.2 inference alerts to simultaneous 12-lead continuous Holter ground truth.
Intended Use → CLM-01 → CLN-088 → DS-VAL-880 → 510(k) K240982
Transform your Clinical Evaluation Reports from static dead binders into living, mathematically backed claims connected directly to your product knowledge graph.