AI-powered strategyand execution for MedTech.
CAHIR Solutions builds AI workspaces that take MedTech teams from market selection to regulatory-ready documentation — without the guesswork.
From market decision to submission clarity
Most MedTech teams face two disconnected questions: where to launch and how to get regulatory-ready. CAHIR's AI products answer both in connected workspaces.
MedTech Compass
MedTech regulatory triage and medical device market intelligence across 25+ markets. Multi-dimensional global scoring, payment forecasting, custom weights, and evidence-grounded answers for global FDA pathways and EU MDR/UKCA routes.
Explore MedTech CompassMedTech Copilot
AI medical device documentation and MedTech QMS software that structures device development with automated design history files and keeps every record audit-ready.
Explore MedTech CopilotDevicePath
Open-source regulatory triage. Describe your device and get its likely FDA class, candidate product codes, probable pathway (510(k), De Novo, PMA or exempt), real 510(k) predicate candidates with K-numbers, and high-level EU MDR and UKCA/MHRA considerations — in seconds.
Latest MedTech insights
Analysis on FDA pathways, EU MDR and UKCA routes, AI-enabled devices and where medical device teams should launch next.
Design history file requirements: what belongs in a medical device DHF
What a design history file must contain under 21 CFR 820.30 and ISO 13485, how the DHF relates to the DMR and DHR, and how to keep it audit-ready.
Read articleUKCA marking for medical devices: MHRA registration and the route to Great Britain
What UKCA marking requires for medical devices, how MHRA registration and UK Responsible Person duties work, and how the Great Britain route differs from EU MDR.
Read articleEU MDR classification rules: how to classify a medical device under Annex VIII
A practical walkthrough of EU MDR classification: the Annex VIII rules, Class I to III, Rule 11 for software, and what each class means for conformity assessment.
Read articleEnterprise-grade security
MedTech Compass is built with layered controls across infrastructure, access, and payments — so your regulatory strategy and market intelligence stay yours.
Certified infrastructure
Hosted on cloud infrastructure that maintains SOC 2 Type II and ISO 27001:2022 certifications.
Organization-scoped isolation
Row Level Security scopes every record to your organization. No cross-tenant access, by policy and by design.
PCI-DSS payments
Payments processed by Stripe (PCI-DSS Level 1). Card and bank details never touch CAHIR servers.