Product modules
Give every contributor—from product leadership to regulatory reviewers—the context and tools they need without creating another data silo.
Product-family workspace
Select a product family to explore its pathway context.
Regulatory pathway workspace
Active product
CardioSense Monitor
Lead authority
FDA · CDRH
Overall readiness
86%
510(k) Premarket Notification
Based on product profile, intended use, primary mode of action, and selected market.
Available pathways
Standalone modules
Each module has its own records, workflows, oversight, and embedded AI assistance while remaining connected to every product family.
CyberHealth
Continuously connect assets, SBOMs, threats, vulnerabilities, controls, incidents, patches, and regulatory decisions.
QMS
Explain quality-system gaps, identify compliance risks, recommend corrective actions, generate controlled drafts, and route critical outputs for expert review.
Clinical Evidence
A focused regulatory evidence workspace for studies, sites, essential documents, safety, and submission traceability.
Labeling & Ad/Promo
Control labeling and promotional review from intake through claims evidence, approval, authority submission, and global alignment.
Post-Market
Turn complaints and external signals into controlled reportability, vigilance, trend, recall, and CAPA workflows.
Module 01
Continuously monitor authorities, guidance, standards, and product-level impact.
Module 02
Compare classifications, pathways, evidence, and registration obligations across markets.
Module 03
Find evidence gaps and prioritize the work that moves every submission forward.
Module 04
Coordinate approvals, renewals, changes, commitments, and post-market obligations.
Module 05
Navigate the unique evidence and jurisdictional complexity of advanced therapies.
Built around your team
eeRegOS supports judgment instead of replacing it—giving each person shared context, traceable evidence, and a clear path to the next decision.
See portfolio risk, evidence, and decisions without chasing updates across systems.
Move from research to documented recommendations with sources and context intact.
Coordinate gaps, reviews, tasks, and submission evidence through accountable workflows.
Understand the next regulatory decision and bring the right experts in at the right time.
Start with one module or connect the full regulatory lifecycle.