RegDesk
RegDesk is an AI-powered Regulatory Information Management platform built specifically for medical device and in vitro diagnostics manufacturers, centralizing global submissions, standards tracking, change management, and distributor collaboration across 120+ markets. It is sold as enterprise SaaS to large life sciences manufacturers.
- Company typePrivate
- Founded2014
- HeadquartersPhiladelphia, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What RegDesk does
RegDesk, Inc. is a Philadelphia-headquartered software company that builds an AI-powered Regulatory Information Management (RIM) platform purpose-built for medical device and in vitro diagnostics manufacturers. The platform centralizes regulatory submissions, registrations, standards tracking, change management, and distributor collaboration across 120+ markets, integrating live regulatory intelligence with compliance data and exposing its capabilities through versioned REST APIs and event-driven webhooks.
The product surface is delivered as a unified RIMS composed of modular capabilities: Regulatory Intelligence (real-time updates from 120+ markets), AI Regulatory Tools / AI Forms and Submission Generator (auto-population of GSPR checklists, Essential Principles Requirements, and Declaration of Conformity forms, plus translation into 50+ languages), Tracking and Reporting (global registration tracking with KPI analytics), Change Assessment (four-stage workflow with AI-driven impact analysis), Standards Management (coverage of 200,000+ country-specific standards across ISO, ASTM, YY, and others), and a Distributor Collaboration Tool. The platform is SOC 2 Type II, 21 CFR Part 11, GDPR, and GxP compliant and is recognized as a Gartner Representative Vendor for both Regulatory Information Management and Regulatory Intelligence.
RegDesk monetizes through enterprise SaaS subscriptions sold via a direct field-sales motion that begins with a demo request and includes onboarding, validation, training, and ongoing customer success. Pricing is not publicly disclosed and is negotiated against customer requirements. The customer base spans large medical device and life sciences enterprises (Thermo Fisher Scientific, Zoll, Steris, Hologic, Waters, Integer, CareDx, Butterfly Network, Owlet, HighRidge Medical, Anika, Origen Biotech, Reva) plus adjacent consumer-goods and financial-services reference accounts (Helen of Troy, Mizuho). Only $50,000 of seed funding from Dreamit Ventures in 2014 is disclosed, and the company has since operated without a publicly documented additional capital event, sized at 11-50 employees.
RegDesk firmographics
Firmographics- Name
- RegDesk
- Legal name
- RegDesk, Inc.
- Website
- https://regdesk.co
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- RegDesk is an AI-powered Regulatory Information Management platform built specifically for medical device and in vitro diagnostics manufacturers, centralizing global submissions, standards tracking, change management, and distributor collaboration across 120+ markets. It is sold as enterprise SaaS to large life sciences manufacturers.
- Ownership category
- akta.pro rank
RegDesk industry classification
Industry- Product category
- Regulatory Compliance Software
- NAICS
- Computer Systems Design and Related Services (5415), Custom Computer Programming Services (541511)
- SIC
- Services-Computer Programming, Data Processing, Etc. (7370)
- akta.pro primary industry
- Regulatory Compliance Management (RegTech) (BPAEAPAB)
- akta.pro secondary industries
- Regulatory Reporting & Compliance Automation (FinCEN/CTR/SAR, EMIR/MiFID, etc.) (FSAGAFAG), GRC, Policy Management & Controls Testing (SOX/ICFR, audit management) (FSAGAFAM)
Keywords
Where RegDesk is headquartered
LocationHeadquarters
- HQ city
- Philadelphia
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
RegDesk business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Infrastructure
Revenue model
- SaaS Subscription Platform: RegDesk operates as a cloud-based SaaS platform providing regulatory information management software for medical device companies. The subscription model includes access to the RIMS platform, regulatory intelligence, AI-powered submission tools, and integration capabilities.
Distribution channels1 record
Marketing channels8 records
RegDesk product offering
Product offeringCore offering
RegDesk provides a cloud-based Regulatory Information Management (RIM) platform built specifically for medical device manufacturers, consolidating global regulatory compliance, submission automation, standards tracking, change management, and distributor collaboration into a single SaaS system. The platform delivers real-time regulatory intelligence from 120+ markets and AI-powered auto-population of complex regulatory forms such as GSPR checklists, Essential Principles Requirements, and Declaration of Conformity, supporting enterprises managing FDA, EU MDR, and multi-jurisdiction submissions.
Product overview
RegDesk is a unified Regulatory Information Management (RIM) platform designed specifically for medical device manufacturers. The core RIMS platform connects compliance data with live regulatory intelligence and includes multiple integrated modules: Regulatory Intelligence (real-time updates from 120+ markets), AI Regulatory Tools/AI Forms and Submission Generator (auto-populates forms with AI and translates to 50+ languages), Tracking and Reporting (global registration tracking with KPI analytics), Change Assessment/Regulatory Change Management (four-stage workflow with AI-driven impact analysis), Standards Management (200,000+ country-specific standards), and Distributor Collaboration Tool (secure document sharing). The platform is complemented by EU MDR Essentials resources, a Public API for enterprise integrations, and Customer Success services. The platform integrates with enterprise systems including ERP (SAP, Oracle, Microsoft Dynamics), PLM (Windchill, Teamcenter), QMS (MasterControl, Qualio), CRM (Salesforce), SSO (Okta, Azure AD), and analytics platforms (Snowflake, Databricks).
Differentiator
Problem solved
Functional benefit
Products and services
- RIMS (Regulatory Information Management System) The intelligent RIM platform built specifically for medical device manufacturers that connects compliance data with live regulatory intelligence, streamlining submissions and enabling smarter regulatory workflows for medtech companies.
- Regulatory Intelligence Module providing real-time regulatory updates from over 120 markets, enabling medical device companies to stay ahead of evolving global regulations including chemical/substance regulations like RoHS and REACH, with AI-driven monitoring and proactive notifications.
- AI Regulatory Tools (AI Forms and Submission Generator) AI-powered tool that auto-populates complex regulatory forms for medical device manufacturers including GSPR checklists, Essential Principles Requirements, and Declaration of Conformity forms, with smart autofill, AI translation into 50+ languages, and automated checklist generation.
- Tracking and Reporting Centralized medical device registration tracking software that replaces spreadsheets with powerful tracking and reporting on a global scale, featuring real-time visibility into submissions and approvals, automated notifications, and KPI analytics for executive reporting.
- Change Assessment (Regulatory Change Management) Regulatory change management software with a four-stage workflow (Start Assessment, Task Strategy, Approve, Create Workflow) that empowers teams to track, analyze, and adapt to evolving regulatory changes with real-time monitoring and AI-driven impact analysis.
- Standards Management Medical device standards management solution that tracks over 200,000 country-specific standards, providing real-time alerts on changes, workflows for gap analyses, and streamlined documentation for ISO, ASTM, Chinese International Standards (GP), Chinese Industry Standards (YY), and Global Harmonized Standards compliance.
- Distributor Collaboration Tool Centralized platform connecting manufacturers and distributors with secure document sharing, submission workflows, and real-time visibility for regulatory compliance across global markets.
- Public API Versioned REST APIs enabling enterprise system integration with event-driven webhooks, supporting data synchronization between RegDesk and enterprise systems like ERP, PLM, QMS, and CRM platforms.
Quantifiable outcome
- 196% ROI (Forrester Total Economic Impact study)
- +7 more outcomes
Companies that use RegDesk
Customer profileNamed customers21 records
Segments2 records
Ideal customer profiles3 records
RegDesk technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration29 records
AI capability7 records
Feature6 records
RegDesk partnerships and signals
Strategic signalPartnerships
13 partnerships are on record, tiered core.
- SAPcoreIntegration partnership allowing ERP product and supply chain data to sync with RegDesk registrations, market availability, and regulatory workflows.
- OraclecoreIntegration with Oracle ERP and CRM systems for regulatory data synchronization and market approval status visibility.
- Microsoft DynamicscoreIntegration with Microsoft Dynamics for ERP and supply chain connectivity to regulatory workflows.
- PTC WindchillcorePLM integration to align submissions, registrations, and change control with released design data from Windchill.
- Siemens TeamcentercorePLM integration for approved product structures, specifications, and change events into RegDesk.
- MasterControlcoreeQMS integration so quality events and controlled documents support regulatory assessments and submission workflows.
- OktacoreSingle Sign-On integration for secure, frictionless access aligned with corporate Identity and Access Management policies.
- Azure Active DirectorycoreSSO integration with Microsoft enterprise identity platform for user lifecycle management.
- SalesforcecoreCRM integration connecting RegDesk tracking data including approval status and market availability with GTM systems.
- SnowflakecoreCloud data platform integration for publishing regulatory, product, and registration data for reporting and analytics.
- DatabrickscoreCloud analytics platform integration for regulatory data analytics and compliance monitoring.
- Jira SoftwarecoreProject management integration connecting change control activities and regulatory deliverables with project tools.
- Azure DevOpscoreDevelopment operations integration for regulatory timeline planning and tracking.
Scale indicators9 records
Recent moves6 records
Expansion highlights6 records
RegDesk competitors and assessment
Company assessmentMarket position
Competitive moat5 records
Key highlights7 records
Customer concentration
RegDesk social profiles
Digital presenceRegDesk compliance and trust
Trust signalCompliance4 records
RegDesk financial estimates
Financial estimateRevenue estimate
Valuation estimate
RegDesk leadership team
Management profileNumber of profiles
Profiles2 records
RegDesk funding detail
Funding detailFunding overview
Funding rounds1 record
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
RegDesk M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about RegDesk
What does RegDesk do?
RegDesk provides a cloud-based Regulatory Information Management (RIM) platform built specifically for medical device manufacturers, consolidating global regulatory compliance, submission automation, standards tracking, change management, and distributor collaboration into a single SaaS system. The platform delivers real-time regulatory intelligence from 120+ markets and AI-powered auto-population of complex regulatory forms such as GSPR checklists, Essential Principles Requirements, and Declaration of Conformity, supporting enterprises managing FDA, EU MDR, and multi-jurisdiction submissions.
Is RegDesk a public or private company?
RegDesk is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was RegDesk founded?
RegDesk was founded in 2014. It employs 11 to 50 people.
Where is RegDesk based?
RegDesk is headquartered in Philadelphia, United States, in the North America region.
How does RegDesk make money?
One revenue line is on record: saaS Subscription Platform.
Does RegDesk have an API?
Yes. Versioned REST APIs built for reliable, long-term system integration with event-driven notifications via webhooks. Features consistent data models that simplify mapping between RegDesk and enterprise systems, plus enterprise-grade authentication, authorization, and access monitoring. API exposes detailed regulatory workflows, data structures, and integration patterns. Documentation access is restricted to customers and approved integration partners. Developer documentation is at www.regdesk.co/integrations.
What industry is RegDesk in?
RegDesk's product category is Regulatory Compliance Software. Its primary akta.pro industry code is BPAEAPAB, Regulatory Compliance Management (RegTech), with a secondary code of FSAGAFAG, Regulatory Reporting & Compliance Automation (FinCEN/CTR/SAR, EMIR/MiFID, etc.). Its NAICS code is 5415 and its SIC code is 7370.