Orcanos
ALM & QMS for Medical Device.
Overview
Orcanos provides an integrated platform for Application Lifecycle Management (ALM) and Quality Management System (QMS) specifically designed for the medical device industry. It helps companies manage their design controls, risk management, and quality processes in a single system to ensure compliance with regulations like FDA 21 CFR Part 820 and ISO 13485.
✨ Key Features
- Design Control
- Risk Management (ISO 14971)
- Document Control
- CAPA Management
- Requirements Management
- Test Management
- Electronic Signatures
🎯 Key Differentiators
- Integrated ALM and QMS in a single platform
- Strong focus on the medical device industry
- End-to-end traceability from requirements to release
Unique Value: Provides a single source of truth for both product development and quality management, streamlining compliance and accelerating time to market for medical device companies.
🎯 Use Cases (4)
✅ Best For
- FDA 21 CFR Part 11 and Part 820 compliance
- ISO 13485 and ISO 14971 compliance
💡 Check With Vendor
Verify these considerations match your specific requirements:
- Non-medical device industries
- Companies that do not require integrated ALM and QMS
🏆 Alternatives
Offers a more integrated solution for design controls and quality management compared to separate ALM and QMS tools, reducing the risk of data silos and compliance gaps.
💻 Platforms
🔌 Integrations
🛟 Support Options
- ✓ Email Support
- ✓ Live Chat
- ✓ Phone Support
- ✓ Dedicated Support (Varies by plan tier)
🔒 Compliance & Security
💰 Pricing
✓ 14-day free trial
Free tier: N/A
🔄 Similar Tools in GMP Software
MasterControl Quality Excellence
Integrated quality management system (QMS) for regulated industries....
Veeva Vault Quality
Cloud-based quality management suite for the life sciences industry....
TrackWise Digital
Cloud-based enterprise quality management software (QMS)....
ComplianceQuest
AI-powered EQMS, EHS, and PLM solution built on the Salesforce platform....
ETQ Reliance
A flexible and comprehensive quality management system (QMS)....
Qualio
Cloud-based quality management system for life sciences companies....