Embedded Where the Work Happens With Rimsys AI
Rimsys AI runs inside the workflows your team already uses. Every recommendation is grounded in structured regulatory data and traceable back to its source, so submissions move faster without asking your team to take the output on faith.
Rimsys AI is not a separate tool. It is embedded where regulatory work happens, supporting market entry, submissions, impact assessment, and ongoing change management.
"Reducing the administrative burden so regulatory teams can focus on strategy has always been our goal. With the Rimsys new AI capabilities, they can apply their expertise at a scale and speed that wasn’t possible before."
- Head of Regulatory Affairs, Global MedTech
How Rimsys AI Works
Two Products.
One Layer of Intelligence.
Rimsys AI is the infrastructure underneath Market Access and RIM, not a feature bolted onto either one.
Market Manager Agents trained on the regulatory framework of 200+ countries, feeding both platforms
Workflows combine agents into outcomes, whether that’s a market entry plan in Market Access or a submission readiness check in RIM
Every recommendation is traceable to the specific regulation, standard, or requirement behind it
Built for execution, not conversation
Outcomes
Measurable Advantages of Intelligent Regulatory Workflows
Rimsys AI drives measurable improvements across regulatory operations:
Reduce repetitive submission work
Automate content preparation, reuse, and formatting to eliminate manual effort
Accelerate impact assessment
Automatically connect regulatory changes to affected products and markets
Deliver clear regulatory recommendations
Surface relevant actions based on real data and regulatory context
Improve decision confidence
Every output traces back to the specific regulation, standard, or requirement behind it, so your team can verify it rather than take it on trust.
Minimize manual research
Continuously monitor and prioritize global regulatory changes
Capabilities
Core Capabilities of Rimsys AI
Rimsys AI supports regulatory execution across key workflows:
Submission Content Reuse and Transformation
Regulatory Impact Recommendation Engine
Intelligent Change Monitoring
Contextual Recommendations
Structured Evaluation Support
Submission Content Reuse and Transformation
Reuse existing submission content across markets and formats. Generate, summarize, and refine documents directly within the platform.
Reusing 510(k) v3 submission content
→ Mapping to EU MDR Annex II
→ Summarizing clinical section (§6)
→ Formatting for EU MDR template
✓ Ready for human review
Regulatory Impact Recommendation Engine
Analyze regulatory changes and recommend actions based on affected products, registrations, and markets
Analyzing regulatory change: IEC 62304:AMD2
→ Scanning portfolio (14 affected SKUs)
→ Assessing markets: EU, UK, CA, AU
→ Recommending gap assessment + remediation plan
✓ Assigning owners for execution
Intelligent Change Monitoring
Continuously monitor regulatory updates across 90+ countries and prioritize what matters most
Monitoring global regulatory landscape (90 countries)
→ Processing 2,418 updates / 30 days
→ Ranking relevance to portfolio
→ Identifying 6 high-priority items
✓ Alert delivered
Contextual Recommendations
Provide guidance grounded in product structure, risk class, and regional requirements
Recommending regulatory pathway for Product P-2491
→ Class IIa under MDR
→ Region: Germany (Notified Body 0123)
→ Next: Annex II technical file refresh
✓ Rationale recorded for audit trail
Structured Evaluation Support
Support impact surveys and assessments with AI-assisted scoping and analysis
Supporting structured evaluation: Q4 impact assessment
→ Pre-filling 38/52 fields
→ Identifying 4 conflicts for SME review
→ Generating evidence bundle
✓ Awaiting reviewer input
Purpose-Built
AI Built Specifically for MedTech
Rimsys AI is purpose-built for medical device regulatory operations.
Purpose-built regulatory intelligence for medical devices:
Designed around MedTech regulatory workflows
Built on structured regulatory data and product hierarchies
Outputs are explainable and audit-ready
Aligned to real regulatory processes and requirements
Enterprise requirements are built in:
Tenant-isolated environments
SOC 2 Type II and ISO 42001 compliant
No customer data used to train external models
Full control over AI usage and configuration
Rimsys AI Capabilities
Designed for Global MedTech Regulatory Leaders
Rimsys AI supports regulatory execution across key workflows:
.avif)
.svg)
Governance & Security
Enterprise-Grade AI Governance and Security
Rimsys AI is designed for regulated environments where control and auditability are required.
SOC 2 and ISO 42001 certified infrastructure
Single-tenant data isolation
No external model training on customer data
Every recommendation is traceable to the specific regulation behind it
Human review remains central to every decision
Experience Intelligent Regulatory Management
See how Rimsys AI transforms regulatory execution across submissions, impact assessment, and global compliance workflows.
FAQs
AI is used to automate repetitive tasks, monitor regulatory changes, and provide context-aware recommendations based on product and market data. In Rimsys, AI is embedded directly into regulatory workflows.
Yes. Rimsys AI automatically connects regulatory changes to affected products, registrations, and markets, helping teams assess impact faster and more accurately.
Rimsys AI is built into RIM. It operates within submissions, intelligence, and impact workflows using structured regulatory data.
No. Rimsys AI enhances human decision-making. It provides recommendations and analysis, but regulatory teams remain fully responsible for final decisions.
Rimsys AI operates in tenant-isolated environments, is SOC 2 and ISO 42001 compliant, and does not use customer data to train external models.
General AI tools draw from the open web and aren't grounded in a specific, current regulatory corpus, so they can't reliably support decisions with real regulatory consequences. Rimsys AI runs against a curated regulatory corpus built for MedTech, embedded directly in your submission, impact, and change workflows, and traces every output back to the specific regulation behind it.
Every output is source-linked back to the specific regulation, guidance, or standard behind it, so your team can verify it rather than take it on faith. Human review remains part of every workflow before a recommendation is finalized.
Rimsys AI draws on a curated regulatory corpus spanning more than 200 markets, built specifically for MedTech regulatory work rather than pulled from the open web.
Yes. Rimsys AI works from your structured product, submission, and market data inside the platform, so recommendations are grounded in your current, controlled information rather than generic assumptions.
Yes. Rimsys AI is powered by the same infrastructure layer underpinning RIM, which is ISO 27001 and ISO 42001 certified.
No. Rimsys AI runs on infrastructure that does not use customer data to train external models.
