The Heart of Regulatory Operations
From market-entry decision to execution, in one connected system.
Rimsys connects AI-native market planning with AI-embedded regulatory execution, giving medtech manufacturers a single system instead of a fragmented, market-by-market process.
Trusted by 6 of the top 12 global MedTech manufacturers
We have repeatedly been a RIM leader on G2.
How Rimsys Works
Two Products.
One Layer of Intelligence.
Regulatory AI Workforce
Regulatory AI Workforce
Rimsys AI runs against a curated regulatory corpus, not the open web, with every output linked back to the specific regulation behind it.
Proven Across
Global Regulatory Operations
Six of the world’s top 12 medical device manufacturers rely on Rimsys to manage and streamline global regulatory operations
Product Philosophy
What You Get on Day One:
Enterprise-Grade Foundation, Human-Centered Design
“Enterprise” often implies slow, rigid, and difficult to adopt. Rimsys proves otherwise.
Built specifically for MedTech, the platform combines:
As portfolios expand and global markets multiply, most organizations rely on:
Enterprise Architecture
- A structured, product-centric data model
- Robust APIs and BI integrations
- Event-driven architecture
- Single-tenant environments
- SOC 2, ISO 42001 and ISO 27001 certification
As portfolios expand and global markets multiply, most organizations rely on:
User Experience
- An intuitive, modern interface
- Logical module design with optional AI power
- High adoption across RA teams
- Unlimited internal and external user licensing
Use Cases
Capabilities That
Eliminate Manual Work
Rimsys focuses on jobs to be done-not feature lists.
Plan expansion, align stakeholders, and generate new registrations from structured product data.
Best for:
Regulatory leaders and growth-focused executives.
Centralize submission preparation, documentation, and review to reduce back-and-forth and eliminate data silos.
Best for:
Regulatory Affairs teams managing heavy submission volume.
Automated reminders and lifecycle tracking keep approvals current across 100+ markets.
Best for:
Global registration managers.
Assign tasks, conduct structured change assessments, and collaborate across teams when product or regulatory changes occur.
Best for:
Change control and cross-functional stakeholders.
Native Universal UDI functionality supports structured global compliance, including EUDAMED requirements
Best for:
Teams managing complex device portfolios.
Accelerate Regulatory Work
AI Designed for
Real Regulatory Workflows
AI in regulatory operations must be trustworthy, explainable, and controlled.
Rimsys AI is embedded directly within regulatory workflows and built on MedTech-specific data structures. It enhances human judgement—it does not replace it.
AI is available as a configuration option for organizations ready to accelerate regulatory work.
Accelerators Include:
Faster submission preparation through automated content support
Earlier identification of regulatory impact through automated content support
Intelligent tracking of evolving global requirements
Reduced time spent on repetitive regulatory tasks
Built for Every Stakeholder
One platform for everyone
RegOps/Regulatory Affairs
Emphasize visibility, fewer manual handoffs, audit readiness, and confidence in regulatory status.
Digital Transformation Leaders
Centralize regulatory data, standardize workflows, and measure efficiency across the organization
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IT
Leverage a structured, product-centric data model with robust APIs, developer support, AI-assisted code generation, BI integration, and single-tenant security architecture
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Start Building
Connected Regulatory Operations
Regulatory complexity is not slowing down.
The organizations that win, treat regulatory operations as a strategic growth engine-not an administrative burden.
Rimsys transforms regulatory operations into the heart of compliant growth-bringing speed, visibility, and confidence to global expansion.
FAQs
A unified RIM platform connects registrations, submissions, product data, and change management into one structured operational system. Traditional RIM systems often digitize isolated tasks and serve as a system of record instead of optimizing workflows. Rimsys also uniquely includes UDI to create a continuously connected regulatory operation.
By centralizing global regulatory intelligence, approvals, risk classifications, and selling status, Rimsys enables faster, more confident market entry and expansion decisions.
Structured data models, governed workflows, and real-time traceability ensure compliance while eliminating manual bottlenecks.
Rimsys AI is explainable, context-aware, and embedded within regulatory workflows. It proposes and analyzes—your team reviews and approves
Yes. Robust APIs and event-driven BI integrations connect regulatory intelligence to enterprise dashboards and downstream systems
Rimsys uses a proven, high-touch implementation approach guided by a RIM & AI Maturity Model - helping organizations modernize in structured, incremental phases
Market Access is a self-serve multi-tenant platform where an organization can get started immediately, without any implementation.
