Med-Tech companies face mounting regulatory burdens at every stage—from initial submission through post-market life. Your team struggles with:
Disconnected classification and labelling
Compliance Blind spots - Missing critical updates from EU MDR or MHRA guidance due to information overload
Lack of agility in submission documentation and adapting to changes
Growing post-market surveillance (PMS) and vigilance obligations
Limited visibility into regulatory cost and financial risk
Difficulty scaling compliance across multiple markets
Unpredictable costs from submission delays, consultant fees and post-market obligations
The result? Delayed market entry, compliance gaps, inflated budgets, and competitive disadvantage. Traditional regulatory tools are static, document-focused, and poorly suited to continuous post-market compliance.
VitaRegX: Beyond Pharma. Built for MedTech. Powered by AI
We have built the first end-to-end agentic AI platform that manages Med-tech product compliance from pre-market submission through post-market surveillance—intelligently, efficiently, and cost-effectively. From initial classification through regulatory submission, to ongoing PMS and global expansion, we help you stay compliant, proactive, and financially informed throughout the entire product lifecycle.
VitaRegX: Beyond Pharma. Built for MedTech. Powered by AI We have built the first end-to-end agentic AI platform that manages Med-tech product compliance from pre-market submission through post-market surveillance—intelligently, efficiently, and cost-effectively. From initial classification through regulatory submission, to ongoing PMS and global expansion, we help you stay compliant, proactive, and financially informed throughout the entire product lifecycle.