Smarter, Faster, Built for Medtech
Harness the power of Rimsys AI, a suite of intelligent AI Agents designed exclusively for MedTech and seamlessly embedded into your regulatory workflows.
more reliably, while navigating increasing global complexity.
With Rimsys AI, we’re giving them the ability to work smarter,
with greater confidence in the quality of their outcomes."
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James Gianoutsos, CEO
The Future of Regulatory Affairs is Intelligent
MedTech regulatory teams face growing challenges: shorter timelines, limited resources, and highly repetitive, manual work. Traditional digital tools and processes can no longer keep up. Competitors and spreadsheets may manage data, but they don’t reduce repetitive work or deliver the insights regulatory teams need to move faster and stay ahead.
Rimsys AI changes this by embedding secure, explainable AI directly into your regulatory workflows, helping teams get products approved faster, bring innovations to market sooner, and stay ahead of compliance risks.
Empowering, Not Replacing, Regulatory Professionals
Rimsys AI is designed to support—not replace—regulatory professionals. Built by regulatory experts, Rimsys AI reflects the context, judgment, and deep product knowledge required to make confident decisions.
AI assists, you decide. Rimsys AI recommends content, analyzes changes, and surfaces alerts, but your team always reviews and approves.
Free your experts for higher-value work. By automating repetitive, time-consuming tasks, Rimsys AI gives regulatory professionals more time to focus on strategic initiatives like market expansion and product launches.
Confidence you can trust. Every AI recommendation is explainable, context-aware, and built on Rimsys’ deep understanding of MedTech regulatory complexities.
AI That Understands MedTech
Rimsys AI is purpose-built for MedTech regulatory operations. Every recommendation is context-aware, traceable, and aligned with industry best practices.
Rimsys AI is different because it is:
Designed specifically for MedTech, not adapted from other industries.
Integrated directly into your Rimsys workflows without requiring extra tools or migrations.
Every AI decision includes context, so you know why and how it was generated.
Built with tenant-isolated environments aligned to SOC 2 Type II and ISO 27001 certifications, and never trained on customer data.
AI Agents Designed for Regulatory Teams
Rimsys AI is powered by a suite of AI agents: intelligent assistants purpose-built to handle high-value regulatory tasks. Each agent focuses on a specific function within your workflows, helping you work smarter without adding complexity.
Eliminate Repetitive Submission Work
Ever wish you didn’t have to rebuild the same submission sections over and over? Rimsys AI removes that burden by automatically identifying and transferring previously approved content into new submissions, giving your team a validated foundation instantly. By accelerating submission preparation, Rimsys AI helps you bring products to market faster, unlocking revenue opportunities and keeping your business competitive.
Get Clear, Confident Recommendations on Change Impact
When products or regulations change, understanding the downstream impact can feel overwhelming. Rimsys AI analyzes your existing data and shows exactly which submissions, registrations, and certificates are affected. By providing clear, actionable recommendations, Rimsys AI removes the guesswork so your team knows where to focus and how to move forward with confidence.
Never Miss a Critical Regulatory Update
Global requirements are constantly evolving, and missing an update can put compliance and market access at risk. Rimsys AI continuously monitors regulatory changes across regions and delivers real-time alerts directly inside the platform. You’ll always know when new guidances or regulations could impact your products, giving your team the visibility needed to respond quickly and stay ahead.
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