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What is RAMS?

The Regulatory Affairs Management Suite (RAMS) by Emergo, a UL company, provides a comprehensive software-as-a-service platform designed to streamline regulatory and quality management for businesses in the medical device and in vitro diagnostics sectors. Leveraging deep regulatory compliance knowledge, RAMS offers an array of tools that enable users to adeptly maneuver through the complex and evolving landscape of global medical device regulations. A notable feature includes product classification, which helps users by leading them through a systematic series of questions to determine or verify their device classifications accurately. The Smart Builder feature provides detailed, step-by-step guidance along with pre-written text to assist in the development of precise regulatory documents, making the process of device registration more efficient and accelerating market access. Additionally, the Registration Tracker automates the management of international certifications and registrations, helping organizations to stay on top of renewals and maintain compliance consistently. By adopting this proactive methodology, companies not only improve their operational efficiency but also effectively mitigate the likelihood of regulatory challenges, allowing them to focus on innovation and growth in the competitive medical device market. Ultimately, RAMS empowers businesses to navigate regulatory landscapes with confidence and agility.

What is Orthogonal?

Orthogonal focuses on providing specialized development services aimed at the design and growth of Software as a Medical Device (SaMD) along with interconnected medical device systems, merging advanced engineering practices with a strong commitment to regulatory compliance. Their approach encompasses the full spectrum of the product lifecycle, incorporating aspects such as user experience design, integration of human factors, requirement specification, risk assessment, Agile software development, and meticulous verification and validation procedures to ensure both safety and operational efficiency. By applying Agile methodologies specifically adapted for regulated environments, they enable iterative development, foster rapid feedback cycles, and support continuous improvements while maintaining adherence to regulatory guidelines such as the FDA, EU MDR, and ISO standards. Additionally, Orthogonal supports the creation of a variety of applications, including mobile, web, and desktop solutions, as well as cloud-based systems, artificial intelligence algorithms, and SDKs that facilitate integration with third-party platforms, allowing medical devices to connect effortlessly, analyze data effectively, and deliver critical insights. This all-encompassing strategy not only leads to innovative solutions that comply with industry benchmarks but also significantly improves patient care and enhances operational productivity, ultimately benefiting healthcare providers and patients alike.

Media

Media

Integrations Supported

AgentMail
Amazon
Andi
Crustdata
Fundable
Gemini
GitHub
Instagram
Klaus
Linkup
OpenAI Codex
Openmart
PredictLeads
Riveter
ScrapeGraphAI
Tavily
TikTok
Tomba
Walmart
X (Twitter)

Integrations Supported

AgentMail
Amazon
Andi
Crustdata
Fundable
Gemini
GitHub
Instagram
Klaus
Linkup
OpenAI Codex
Openmart
PredictLeads
Riveter
ScrapeGraphAI
Tavily
TikTok
Tomba
Walmart
X (Twitter)

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Emergo by UL

Company Location

United States

Company Website

www.emergobyul.com/software/regulatory-affairs-management-suite

Company Facts

Organization Name

Orthogonal

Date Founded

2025

Company Location

United States

Company Website

www.orthogonal.com

Categories and Features

Categories and Features

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