RAPS Convergence 2026
Regulatory Intelligence.
Reimagined.
The only platform purpose-built for medical device regulatory professionals — from first market to global scale.
🏛️
RAPS Convergence 2026
regdesk.co
The RegDesk Platform
Four Pillars of Regulatory Excellence
Plan
Map regulatory pathways across 120+ markets. AI-powered classification and submission strategy — before you commit resources.
Build
Compile compliant submissions with labeling requirements, UDI management, and automated document workflows.
Track
Monitor registrations, renewals, and approvals across your entire portfolio. Real-time dashboards and renewal alerts.
Maintain
Stay ahead of regulatory changes with automated impact assessments. Audit-ready documentation at every step.
Intelligent RIM
AI-Powered Regulatory
Intelligence Engine
01
Change Impact Assessment
Automatically detect regulatory changes and instantly assess impact across every product, SKU, and market in your portfolio. No manual monitoring needed.
02
Smart Classification
AI-driven device classification across 120+ markets. Instantly determine your regulatory pathway before committing engineering resources.
03
Automated Alerts
Never miss a renewal or regulatory update. Real-time monitoring with intelligent notifications mapped to your specific device portfolio.
04
Regulatory Co-Pilot
AI-assisted labeling review, document summarization, and workflow automation — your regulatory team, supercharged.
Enterprise-Grade Validation
Built for Audit.
Ready for Review.
- Full audit trails — Every action, document, and approval automatically captured
- GxP compliance — Supports Good Practice guidelines including electronic records
- 21 CFR Part 11 — Electronic signature and records compliance built-in
- Change management — 4-stage validated workflow from assessment to approval
- Role-based access control — Enterprise identity and permissions management
- SSO & multi-tenant workspaces — Secure collaboration across your organization
✓
Audit-Ready by Design
Not retrofitted. Built from the ground up for regulatory validation.
100%
Automated
Audit Trail
Audit Trail
GxP
Compliance
Supported
Supported
Part 11
21 CFR
Ready
Ready
Trust & Compliance
Security You Can Count On.
Compliance You Can Prove.
Enterprise-grade security infrastructure protecting your most sensitive regulatory data — certified, validated, and auditable.
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SOC 2 Type II
Independently audited security controls. Your data is protected by the gold standard in enterprise security.
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ISO 27001
International standard for information security management systems — verified and maintained.
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21 CFR Part 11
Electronic records and electronic signatures compliance for FDA-regulated environments.
✅
GxP Compliant
Supports Good Practice guidelines including full audit trails and electronic records management.
Global Scale
Trusted at Scale
120+
Markets Covered
Full regulatory depth, not just alerts
Full regulatory depth, not just alerts
250K+
Products Managed
Across global portfolios
Across global portfolios
$2.2B
Market Size (2024)
Growing to $6.2B by 2034
Growing to $6.2B by 2034
11%
CAGR 2024–2034
Fastest-growing RIM segment
Fastest-growing RIM segment
120+ Market Content Database
Deep regulatory guidance — not surface-level alerts. The only platform with this level of device-specific depth.
Device-Focused by Design
Purpose-built for medical device manufacturers — not repurposed pharma software. Every feature built for device regulatory teams.
Distributor Collaboration Tools
Unique in-platform distributor workflow management. A genuine differentiator no competitor has matched.
The RegDesk Difference
From First Market
to Global Scale —
In One Platform.
Most teams manage regulatory with spreadsheets, email threads, and outdated PDFs. RegDesk replaces all of it — with a system that scales with you.
Without RegDesk vs. With RegDesk
❌ Without
Manual tracking in spreadsheets — error-prone, not scalable
✅ With RegDesk
Real-time portfolio dashboard across all markets
❌ Without
Missed renewals discovered late — costly delays
✅ With RegDesk
Automated alerts months in advance, every time
❌ Without
Regulatory changes discovered months after the fact
✅ With RegDesk
AI impact assessment the moment a change is published
Integrations & Ecosystem
Fits Into Your
Existing Stack.
- API access — Read/write API to integrate RegDesk into your existing tech stack
- ERP / PLM integration — SAP, PLM, eDMS, and enterprise systems
- QMS / eQMS integration — Bi-directional sync with quality management systems
- SSO / enterprise auth — SAML, OIDC, and enterprise identity providers
- UDI management — GUDID and EUDAMED via Reed Tech partnership
Self-Service Onboarding
No 6-month implementation. No dedicated consultant required. Get your team onboarded and productive in days — not quarters.
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REST API
Full read/write access
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ERP / PLM
SAP & enterprise systems
✅
QMS
Quality management sync
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SSO
Enterprise identity
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UDI Management
GUDID + EUDAMED via Reed Tech partnership
RAPS Convergence 2026 · Visit Our Booth
Ready to Transform Your
Regulatory Operations?
Speak with our regulatory intelligence experts today. See how RegDesk can help your team move faster, stay compliant, and scale globally.
regdesk.co
Schedule a Demo
120+ Markets
Full Regulatory Depth
SOC 2 · ISO 27001
Enterprise Security