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
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 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
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 Videos |
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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 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 |
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Integrations
AgentMail
Amazon
Apollo
Claude Code
ContactOut
Crustdata
Cursor
Didit
Fiber AI
Fundable
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Integrations
AgentMail
Amazon
Apollo
Claude Code
ContactOut
Crustdata
Cursor
Didit
Fiber AI
Fundable
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