About
RegDesk is a Regulatory Information Management System (RIMS) that helps medical device companies manage global regulatory submissions, product registrations, and compliance in one centralized platform. It streamlines regulatory workflows, organizes regulatory data, and provides global regulatory intelligence to help teams navigate complex requirements across multiple markets. Regulatory affairs and quality teams benefit by reducing manual work, improving submission accuracy, and accelerating time to market.
Our capabilities are as follows:
• AI Application Builder
• Regulatory Intelligence
• Change Assessment
• Standards Management
• Country-Specific Templates
• Distributor Collaboration
• AI Document Management
• Tracking & Reporting
• Alerts and Notification
• Product Management
• Claims Management
• EUDAMED
For more information, visit our website.
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About
RegPass™ is the compliance co-pilot built to 10× your team’s impact. From horizon scanning to assurance, RegPass connects every stage of the regulatory change lifecycle: Horizon Scanning → Rules Inventory → Policies & Controls → Regulatory Policy Advisor.
Stay ahead with comprehensive global coverage and intelligent Business Profiles that filter alerts to what’s truly relevant. Our enriched Rules Inventory consolidates overlapping obligations into canonical ones for clarity and traceability.
AI sits at the heart of RegPass, extracting, prioritizing, and mapping obligations to your policies and controls with clear rationale. Every suggestion is explained, auditable, and ready for approval.
Built by the experts at Braithwate, RegPass encodes decades of regulatory change experience into a powerful knowledge graph. Open, extensible, and transparent by default, RegPass delivers end-to-end traceability, helping teams work faster, reduce risk, and strengthen compliance.
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Not Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Medical Devices, Pharmaceuticals, and IVD companies
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Audience
Financial Services, Compliance, Legal, COO, Regulatory Change
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Supported
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Screenshots and Videos |
Screenshots and VideosNo images available
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PricingContact us to learn more.
Free Version
Not Supported
Free Trial
Not Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Reviews/
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Reviews/
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Pros from Real UsersPros
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Company InformationRegDesk
Founded: 2014
United States
www.regdesk.co
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Company InformationRegPass
Founded: 2019
United Kingdom
www.regpass.ai
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Categories |
Categories |
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Integrations
Active Directory
Supported
Arena
Supported
Asana
Supported
Boomi
Supported
Dynamics 365 Customer Service
Supported
Jira
Supported
MuleSoft Anypoint Platform
Supported
Okta
Supported
OpenText AI Operations Management
Supported
Oracle ADF Faces
Supported
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Integrations
Active Directory
Not Supported
Arena
Not Supported
Asana
Not Supported
Boomi
Not Supported
Dynamics 365 Customer Service
Not Supported
Jira
Not Supported
MuleSoft Anypoint Platform
Not Supported
Okta
Not Supported
OpenText AI Operations Management
Not Supported
Oracle ADF Faces
Not Supported
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