RAMSEmergo by UL
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Related Products
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About
Orthogonal provides specialized development services focused on building and scaling Software as a Medical Device (SaMD) and connected medical device systems, combining modern engineering practices with strict regulatory compliance. Their approach spans the full product lifecycle, including user experience design, human factors integration, requirements definition, risk analysis, Agile software development, and verification and validation to ensure both functionality and safety. It emphasizes the use of Agile methodologies adapted to regulated environments, enabling iterative development, faster feedback cycles, and continuous improvement while maintaining compliance with standards such as FDA, EU MDR, and ISO frameworks. Orthogonal supports the development of mobile, web, and desktop applications, cloud-based systems, AI algorithms, and SDKs that integrate with third-party platforms, allowing medical devices to connect, process data, and deliver insights.
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About
Emergo by UL's Regulatory Affairs Management Suite (RAMS) is a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for medical device and in vitro diagnostic companies. Leveraging decades of regulatory compliance expertise, RAMS offers a suite of tools to navigate the complex and evolving landscape of global medical device regulations. Key features include product classification, which guides users through a series of questions to determine or verify device classification, and Smart Builder, a tool that provides step-by-step guidance and templated text to create accurate regulatory documentation, facilitating smoother device registration and faster market access. The Registration Tracker automates the tracking of global registrations and certifications, helping organizations avoid missed renewals and maintain 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
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Medical device companies, digital health startups, and healthcare technology teams that need to develop compliant, scalable software for connected medical devices and digital therapeutics
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Audience
Regulatory affairs professionals looking for a solution to streamline compliance processes and maintain up-to-date knowledge of global regulatory requirements
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Support
Phone Support
Not 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
Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Not Supported
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Pricing
No information available.
Free Version
Not Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Not Supported
In Person
Not Supported
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Training
Documentation
Supported
Webinars
Supported
Live Online
Not Supported
In Person
Supported
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Company InformationOrthogonal
Founded: 2025
United States
www.orthogonal.com
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Company InformationEmergo by UL
United States
www.emergobyul.com/software/regulatory-affairs-management-suite
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Categories |
Categories |
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Integrations
Andi
Supported
Apollo
Supported
Claude Code
Supported
ContactOut
Supported
Crustdata
Supported
Cursor
Supported
Didit
Supported
Fundable
Supported
Google Calendar
Supported
Instagram
Supported
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Integrations
Andi
Not Supported
Apollo
Not Supported
Claude Code
Not Supported
ContactOut
Not Supported
Crustdata
Not Supported
Cursor
Not Supported
Didit
Not Supported
Fundable
Not Supported
Google Calendar
Not Supported
Instagram
Not Supported
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