Regulatory updates
SOURCE
Official update detected
NMPA New guidance
Medical device registration guidance updated
From regulatory update to clear action.
MedXtion helps medical device teams detect official regulatory changes, understand the impact, and turn them into traceable next steps.
Impact evaluation
TRIAGE
Evaluate the impact
RISKMediumAFFECTSRegistration
Review dossier impact and confirm applicability.
Action record
ACTION
Assign and record
ET
OWNERRegulatory Affairs
In review✓Source and decision trail preserved
Official sources onlySource-to-action traceabilityBuilt for medtech
THE PROBLEM
Regulatory teams don’t need more noise.
Updates are scattered across authorities, standards bodies and public institutes. The real work starts after discovery: deciding what changed, what it affects and who needs to act.
Scattered sources
Regulatory updates are published across multiple official sources.
Manual monitoring
Repetitive checking on official websites, inboxes, newsletters, and professional networks.
The action gap
Updates are detected, but struggle to translate them into timely, accountable internal actions.
THE SOLUTION
One evaluation system. Traceable actions.
MedXtion connects official-source monitoring, AI-assisted impact mapping and a searchable decision trail in one focused workflow.
Detect
Monitor curated official regulatory sources.
Evaluate
Triage impact, risk and urgency.
Act
Assign owners and track next steps.
WHY IT MATTERS
Less monitoring.
Faster decision and action.
The objective is not to replace regulatory evaluation. It is to give specialists better monitoring and triage to focus on the decision and implementation.
Reduce manual effort
Spend less time repeating website checks and consolidating fragmented signals.
Shorten assessment time
Move faster from detection to a structured view of risk, products and functions.
Improve traceability
Preserve a defensible thread from official source to internal owner and action.
Protect market access
Reduce missed deadlines, delayed launches and avoidable compliance exposure.
HOW IT WORKS
Workflow
A focused workflow that keeps each regulatory decision connected to its official source.
Official input
SourceImpact review
TriageOwnership
ActionDecision trail
RecordWHO IT’S FOR
For teams accountable for regulated growth.
Designed for small and mid-sized medical device companies with international market access.
Regulatory Affairs professional
Quality managers
Research and development teams
VISION ROADMAP
Start where the signal gap is hardest.
Pilot module
Planned expansion
Planned expansion
REGULATORY INTELLIGENCE RESOURCES
Understand the signal. Document the action.
Practical introductions to medical device regulatory monitoring and impact assessment across priority markets.
FOUNDATIONS
Medical device regulatory intelligence
Build a source-controlled process from surveillance through accountable action.
EUROPEAN UNIONEU MDR regulatory intelligence
Connect changing guidance and requirements to technical documentation and QMS controls.
CHINAChina medical device regulations
Monitor NMPA and related authorities with a structured applicability review.
BRAZILANVISA regulatory monitoring
Track official notices and assess portfolio, registration, and vigilance impact.
WORKFLOWRegulatory impact assessment
Turn a new source into a reviewable product, process, and evidence decision.
EARLY ACCESS
Let's build the right tool.
We’re speaking with regulatory and quality professionals who manage China market access. Join the early-access list for future pilot testing.
“Regulatory teams do not need more noise. They need an evaluation system with traceable actions.”
MX
MedXtionFounder-led regulatory intelligence