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
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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Platforms Supported
Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook
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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
24/7 Live Support
Online
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Support
Phone Support
24/7 Live Support
Online
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API
Offers API
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API
Offers API
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Screenshots and Videos |
Screenshots and VideosNo images available
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Pricing
No information available.
Free Version
Free Trial
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Pricing
No information available.
Free Version
Free Trial
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Reviews/
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Reviews/
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Training
Documentation
Webinars
Live Online
In Person
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Training
Documentation
Webinars
Live Online
In Person
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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
Archer
Arena
Asana
Boomi
Dynamics 365 Customer Service
Jira
MuleSoft Anypoint Platform
Okta
OpenText AI Operations Management
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Integrations
Active Directory
Archer
Arena
Asana
Boomi
Dynamics 365 Customer Service
Jira
MuleSoft Anypoint Platform
Okta
OpenText AI Operations Management
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