Related Products
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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.
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About
SimplerQMS is an electronic quality management system (eQMS) built by life science experts. It helps life science companies stay compliant with FDA, ISO, and GxP requirements while reducing manual work and improving audit readiness. With SimplerQMS, teams can easily manage documents, change control, training, CAPA, analytics, and more on one cloud-based platform. The system is fully validated, so companies can start quickly without a long validation process.
What customers appreciate most:
• Compliant processes and fewer manual errors
• Fast implementation and smooth data migration
• User training and 24/7 global support
• Guidance from compliance experts throughout the journey
Whether you're a growing startup or an established life science company, SimplerQMS gives you the tools and support to build a strong quality culture and stay audit-ready every day.
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Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Supported
Mac
Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Supported
iPad
Supported
Android
Supported
Chromebook
Not Supported
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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
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Audience
Startups and Growing Life Science Companies – Medical Devices, Pharmaceutical, Biotech, Laboratories, CRO / CMO
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Support
Phone Support
Supported
24/7 Live Support
Not Supported
Online
Supported
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Supported
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Screenshots and Videos |
Screenshots and Videos |
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Pricing
No information available.
Free Version
Supported
Free Trial
Supported
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Pricing
$17,500 / year
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
Free Version
Not Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Company InformationOrcanos
Founded: 2004
Israel
www.orcanos.com
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Company InformationSimplerQMS
Founded: 2017
Denmark
www.simplerqms.com
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Alternatives |
Alternatives |
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Categories |
Categories |
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Application Lifecycle Management Features
Administrator Level Control
Supported
Defect Tracking
Supported
Iteration Planning
Supported
Project Management
Supported
Release Management
Supported
Requirements Review
Supported
Task Management
Supported
Test Case Tracking
Supported
User Level Management
Supported
Version Control
Supported
Requirements Management Features
Automated Functional Sizing
Not Supported
Automated Requirements QA
Not Supported
Automated Test Generation
Not Supported
Automated Use Case Modeling
Not Supported
Change Management
Supported
Collaboration
Supported
History Tracking
Supported
Prioritization
Supported
Reporting
Supported
Status Reporting
Supported
Status Tracking
Supported
Summary Reports
Supported
Task Management
Supported
To-Do List
Supported
Traceability
Supported
User Defined Attributes
Supported
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Audit Features
Alerts / Notifications
Supported
Audit Planning
Supported
Compliance Management
Supported
Dashboard
Supported
Exceptions Management
Not Supported
Forms Management
Supported
Issue Management
Supported
Mobile Access
Supported
Multi-Year Planning
Not Supported
Risk Assessment
Supported
Workflow Management
Supported
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Not Supported
Training Management
Supported
Compliance Features
Archiving & Retention
Supported
Artificial Intelligence (AI)
Not Supported
Audit Management
Supported
Compliance Tracking
Not Supported
Controls Testing
Not Supported
Environmental Compliance
Not Supported
FDA Compliance
Supported
HIPAA Compliance
Supported
Incident Management
Not Supported
ISO Compliance
Supported
OSHA Compliance
Not Supported
Risk Management
Supported
Sarbanes-Oxley Compliance
Not Supported
Surveys & Feedback
Not Supported
Version Control
Supported
Workflow / Process Automation
Supported
Document Control Features
Archiving & Retention
Supported
Automated Routing
Supported
Change Management
Supported
Compliance Management
Supported
Electronic Signature
Supported
Escalation Management
Supported
Periodic Review
Supported
Version Control
Supported
Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Supported
Maintenance Management
Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
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Integrations
Microsoft 365
Supported
Jira
Supported
Microsoft Entra ID
Not Supported
Salesforce
Supported
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Integrations
Microsoft 365
Supported
Jira
Not Supported
Microsoft Entra ID
Supported
Salesforce
Not Supported
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