What is Gamura AI?
Gamura is an AI chatbot that helps MedTech professionals navigate regulations across 18 countries. From US FDA (21 CFR) to EU MDR to Indian MDR 2017, it delivers clear compliance guidance, saving hours of manual research and keeping teams audit-ready.
Problem
MedTech professionals manually research compliance regulations across 18 countries, facing time-consuming manual research and risk of outdated/inaccurate regulatory information.
Solution
AI chatbot tool that provides real-time compliance guidance for medical devices, enabling users to ask questions about FDA, EU MDR, and other regulations with country-specific answers.
Customers
Regulatory affairs managers, medical device compliance officers, and MedTech startup founders needing rapid audit preparation across multiple jurisdictions.
Unique Features
Covers 18 countries' regulations simultaneously, interprets complex legal texts into actionable steps, and maintains updated database of MDR/FDA changes
Traction
Launched 2024, listed on Product Hunt without disclosed revenue/user metrics. Founder profile shows 15+ years in MedTech compliance consulting.
Market Size
Global medical device regulatory affairs market valued at $7.2 billion in 2023 (Grand View Research), growing through AI adoption in compliance workflows.
