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About

Orcanos is a medical device quality and development platform that unifies eQMS, ALM, design control, document control, and risk management in one system. It helps MedTech teams connect R&D and Quality workflows so requirements, risks, validations, documents, and audit evidence stay traceable. The platform supports compliance needs such as ISO 13485, EU MDR, ISO 14971, FDA requirements, and 21 CFR Part 11. Orcanos includes customizable workflows, electronic signatures, document lifecycle automation, training tasks, audit trails, access controls, and centralized quality records. Its integrated ALM tools help teams manage design inputs, verification, validation, DHF readiness, impact analysis, and product development changes. With AI assistance, rapid deployment, and one source of truth for regulated product data, Orcanos helps medical device companies reduce compliance friction and accelerate innovation.

About

QVscribe, QRA's flagship product, unifies stakeholders by ensuring clear, concise artifacts. It automatically evaluates requirements, identifies risks, and guides engineers to address them. QVscribe simplifies artifact management by eliminating errors and verifying compliance with quality and industry standards. QVscribe Features: Glossary Integration: QVscribe now adds a fourth dimension by ensuring consistency across teams using different authoring tools. Term definitions appear alongside Quality Alerts, Warnings, and EARS Conformance checks within the project context. Customizable Configurations: Tailor QVscribe to meet specific verification needs for requirements, including business and system documents. This flexibility helps identify issues early before estimates or development progress. Integrated Guidance: QVscribe offers real-time recommendations during the editing process, helping authors effortlessly correct problem requirements and improve their quality.

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Platforms Supported

Windows
Mac
Linux
Cloud
On-Premises
iPhone
iPad
Android
Chromebook

Audience

Orcanos is best suited for medical device companies, MedTech startups, R&D teams, Quality teams, Regulatory Affairs teams, product development teams, and compliance leaders that need integrated eQMS, ALM, design control, risk management, document control, audit readiness, and traceability

Audience

Organizations interested in a tool that simplifies requirements management by eliminating errors and ensuring adherence to quality and industry standards

Support

Phone Support
24/7 Live Support
Online

Support

Phone Support
24/7 Live Support
Online

API

Offers API

API

Offers API

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version
Free Trial

Pricing

No information available.
Free Version
Free Trial

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

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Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation
Webinars
Live Online
In Person

Training

Documentation
Webinars
Live Online
In Person

Company Information

Orcanos
Founded: 2004
Israel
www.orcanos.com

Company Information

QRA
Founded: 2012
Canada
qracorp.com

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Categories

Categories

Requirements Management Features

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

Application Lifecycle Management Features

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Compliance Features

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
Incident Management
ISO Compliance
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Quality Management Features

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Requirements Management Features

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

Artificial Intelligence Features

Chatbot
For eCommerce
For Healthcare
For Sales
Image Recognition
Machine Learning
Multi-Language
Natural Language Processing
Predictive Analytics
Process/Workflow Automation
Rules-Based Automation
Virtual Personal Assistant (VPA)

Data Quality Features

Address Validation
Data Deduplication
Data Discovery
Data Profililng
Master Data Management
Match & Merge
Metadata Management

Natural Language Processing Features

Co-Reference Resolution
In-Database Text Analytics
Named Entity Recognition
Natural Language Generation (NLG)
Open Source Integrations
Parsing
Part-of-Speech Tagging
Sentence Segmentation
Stemming/Lemmatization
Tokenization

Integrations

IBM DOORS Next
Jama Connect
Jira
Microsoft 365
Microsoft Excel
Microsoft Word
Modern Requirements4DevOps
Polarion REQUIREMENTS
Salesforce

Integrations

IBM DOORS Next
Jama Connect
Jira
Microsoft 365
Microsoft Excel
Microsoft Word
Modern Requirements4DevOps
Polarion REQUIREMENTS
Salesforce
Claim Orcanos and update features and information
Claim Orcanos and update features and information
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Claim QVscribe and update features and information