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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

Ensure timely and budget-friendly delivery of products with Orcanos, a comprehensive software solution for Application Lifecycle Management (ALM) and Quality Management Systems (QMS). This cost-effective cloud-based platform encompasses various functionalities, including Requirements Management, Test Management, Document Control, Risk Management, and Quality Management, all centralized in one repository. Moreover, Orcanos offers intuitive dashboards and real-time alerts, enabling organizations to monitor their projects effectively and maintain visibility on progress as it occurs. The Orcanos e-DMS functions as a complete document management system tailored for users to create, track, search, archive, and approve all documentation pertinent to each phase of launching a medical device. By facilitating quick access to documents related to planning, design, development, manufacturing, and servicing, the e-DMS enhances the efficiency of quality processes while significantly shortening the time to market. Additionally, this streamlined approach allows businesses to focus on innovation and meeting regulatory requirements without sacrificing productivity.

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

Screenshots View All

Screenshots View All

Integrations

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira
Jira Align
Microsoft 365
Redmine
Salesforce

Integrations

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira
Jira Align
Microsoft 365
Redmine
Salesforce

Pricing Details

$69.00/month/user
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

Orcanos

Founded

2004

Country

Israel

Website

www.orcanos.com/compliance/qpack-medical-compliance/

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

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

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

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