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features
design
support

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Write a Review

Description

Orthogonal specializes in offering development services that concentrate on the creation and expansion of Software as a Medical Device (SaMD) and interconnected medical device systems, blending cutting-edge engineering techniques with rigorous adherence to regulatory standards. Their methodology encompasses the entire product lifecycle, which includes elements such as user experience design, integration of human factors, requirement specification, risk assessment, Agile software development, and thorough verification and validation processes to guarantee both operational effectiveness and safety. By utilizing Agile methodologies tailored for regulated settings, they facilitate iterative development, promote quicker feedback loops, and encourage ongoing enhancements while ensuring compliance with regulatory frameworks like the FDA, EU MDR, and ISO standards. Moreover, Orthogonal aids in the development of various applications, including mobile, web, and desktop solutions, along with cloud-based systems, artificial intelligence algorithms, and SDKs that facilitate integration with external platforms, empowering medical devices to connect seamlessly, analyze data, and provide valuable insights. This comprehensive approach allows for innovative solutions that not only meet industry standards but also enhance patient care and operational efficiency.

Description

Emergo by UL's Regulatory Affairs Management Suite (RAMS) is an all-encompassing software-as-a-service solution crafted to optimize regulatory and quality management processes for companies involved in medical devices and in vitro diagnostics. Drawing on extensive expertise in regulatory compliance, RAMS equips users with a range of tools to effectively navigate the intricate and ever-changing realm of global medical device regulations. Among its standout features is product classification, which assists users by guiding them through a structured series of inquiries to ascertain or confirm the classification of their devices. Additionally, the Smart Builder offers comprehensive step-by-step instructions and ready-made text to aid in the creation of precise regulatory documentation, thereby facilitating a smoother path to device registration and expedited market entry. Furthermore, the Registration Tracker serves to automate the oversight of international registrations and certifications, ensuring that organizations do not overlook renewals and consistently uphold compliance standards. This proactive approach not only enhances efficiency but also significantly reduces the risk of regulatory setbacks.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

AgentMail Yes 
Amazon Yes 
Andi Yes 
Claude Code Yes 
ContactOut Yes 
Didit Yes 
Fundable Yes 
Gemini Yes 
Instagram Yes 
Linkup Yes 
Nano Banana Yes 
OpenClaw Yes 
PredictLeads Yes 
Riveter Yes 
ScrapeGraphAI Yes 
Slack Yes 
Tavily Yes 
Walmart Yes 
X (Twitter) Yes 
eBay Yes 

Integrations

AgentMail No 
Amazon No 
Andi No 
Claude Code No 
ContactOut No 
Didit No 
Fundable No 
Gemini No 
Instagram No 
Linkup No 
Nano Banana No 
OpenClaw No 
PredictLeads No 
Riveter No 
ScrapeGraphAI No 
Slack No 
Tavily No 
Walmart No 
X (Twitter) No 
eBay No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) No 
In Person Yes 

Vendor Details

Company Name

Orthogonal

Founded

2025

Country

United States

Website

www.orthogonal.com

Vendor Details

Company Name

Emergo by UL

Country

United States

Website

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

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Product Features

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