Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools.
The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities.
Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.
API Access
Has API
API Access
Has API
Integrations
GitHub
AgentMail
Apollo
ContactOut
Crustdata
Didit
Fiber AI
Fundable
Gemini
Google Calendar
Integrations
GitHub
AgentMail
Apollo
ContactOut
Crustdata
Didit
Fiber AI
Fundable
Gemini
Google Calendar
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
€1300 per year
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Orthogonal
Founded
2025
Country
United States
Website
www.orthogonal.com
Vendor Details
Company Name
Aligned AG
Founded
2007
Country
Switzerland
Website
www.aligned.ch/
Product Features
Product Features
Application Lifecycle Management
Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control
Requirements Management
Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes