AI-powered regulatory intelligenceand market access for MedTech.
CAHIR's MedTech Compass and MedTech Copilot combine medical device market scoring across 25+ markets with FDA, EU MDR and UKCA pathway comparison, submission-ready documentation, and an AI compliance framework built for regulated device teams.
The market reality
Most MedTech teams juggle two disconnected problems: knowing WHERE to launch, and knowing HOW to get regulatory-ready once they commit. Solving them separately wastes time, budget, and momentum.
MedTech Compass
LiveYour MedTech GPS for regulatory intelligence and market access.
MedTech Compass maps FDA 510(k), De Novo, and PMA pathways against EU MDR and UKCA requirements so you can choose the fastest route to market. Score global market attractiveness across 25+ markets with evidence-backed weights, then export executive-ready regulatory summaries that align commercial and regulatory strategy.
Whether you need a quick market signal, a single launch-ready report, or an enterprise-wide intelligence workflow, Compass turns fragmented regulatory data into a clear action plan.
From strategy to submission clarity
- Compare regulatory pathways across FDA, EU MDR, and UKCA
- Score market attractiveness with evidence-backed weights
- Generate executive summaries from structured intelligence
See how MedTech Compass works · See demo cases and market scores
About MedTech CompassMarket Signal
For teams validating one market signal before committing to a full analysis.
Live dynamic market data. Regulatory Analyzer + Geography. Free entry tier.
Single-Market Report
For teams that need one launch-ready market report, accurate and fast. Full dimensions analysis. No subscription needed.
90-day launch offer (100% creditable to Pro or Executive within 90 days)
Pro
For growing MedTech teams running cross-functional strategy, regulatory and commercial analysis. Innovator market access workflow.
Executive
For scaling companies accelerating market entry with premium scoring, integrations and support. Support multiple workflows and decision points.
Portfolio
For established, multi-market organizations standardizing an enterprise-wide intelligence workflow and portfolio features.
An AI compliance framework built for MedTech and AI governance standards
Toggle below to see how the MedTech Compass AI compliance framework aligns with global medical device and AI governance standards — ALCOA+, 21 CFR Part 11, FDA AI guidance and GMLP, ISO 13485 and IEC 42001.
ALCOA+ Data Integrity
Guarantees data is Attributable, Legible, Contemporaneous, Original, and Accurate across all regulatory decision logs.
Built for device teams
MedTech Copilot keeps engineering and documentation in sync so teams can focus on innovation while staying audit-ready.
MedTech Copilot
LiveAI workspace for device development and regulatory documentation.
MedTech Copilot structures your device program into clear phases with predefined milestones, then uses context-aware AI to draft design history files, risk analysis, and evidence summaries. Everything stays in one searchable workspace so engineering and quality stay in sync as you move toward FDA, EU MDR, or UKCA submission.
Built for teams that want to focus on innovation while staying audit-ready — with SOC 2 Type II aligned controls, end-to-end encryption, and no PHI stored in the workspace.
Structured Projects
Break development into clear phases with predefined milestones and deliverables.
AI Copilot
Generate, refine, and organize documentation with context-aware AI assistance.
Organized Documentation
Keep design history files, risk analysis, and evidence in one searchable workspace.
Ready to move from strategy to execution?
MedTech Compass and MedTech Copilot work standalone or together — pick your starting point.
Guides for MedTech teams
- PCCP guide for AI-enabled devices
- 21 CFR Part 11 and electronic records guide
- Competitive intelligence for medical devices
- Regulatory intelligence software
- How MedTech Compass works
- MedTech Compass demo cases
- Medical device market intelligence
- Medical device market access guide
- FDA regulatory pathways
- EU MDR and UKCA compliance
Have a question about device pathways or regulatory guidance? Contact our team.
Both products are operated by CAHIR Solutions. External links open in a new window.