Orcanos

ALM, QMS, and Risk Management for Medical Device.

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Overview

Orcanos provides an integrated platform that combines Application Lifecycle Management (ALM), Quality Management System (QMS), and Risk Management for the medical device and other regulated industries. It helps companies manage the entire product lifecycle, from requirements and development to quality and compliance.

✨ Key Features

  • Application Lifecycle Management (ALM)
  • Quality Management System (QMS)
  • Risk Management (ISO 14971)
  • Document Control
  • e-Signatures (FDA 21 CFR Part 11)
  • Design Control

🎯 Key Differentiators

  • Integrated ALM, QMS, and risk management.
  • Strong focus on the medical device industry.
  • Affordable pricing and a free tier.

Unique Value: Provides a single platform for managing the entire medical device lifecycle, from concept to post-market.

🎯 Use Cases (3)

Managing the development and quality of medical devices and other regulated products. Ensuring compliance with industry standards like ISO 13485 and FDA regulations. Integrating product development and quality management processes.

✅ Best For

  • Medical device software development.
  • ISO 13485 and FDA 21 CFR Part 11 compliance.

💡 Check With Vendor

Verify these considerations match your specific requirements:

  • Companies not involved in product development.
  • Businesses looking for a simple, standalone QMS.

🏆 Alternatives

Greenlight Guru Qualio Jama Software

Offers a more integrated solution for product development and quality management compared to standalone QMS or ALM tools.

💻 Platforms

Web

🔌 Integrations

Jira Jenkins Git API

🛟 Support Options

  • ✓ Email Support
  • ✓ Live Chat
  • ✓ Phone Support
  • ✓ Dedicated Support (Enterprise tier)

🔒 Compliance & Security

✓ HIPAA ✓ BAA Available ✓ GDPR ✓ SSO ✓ FDA 21 CFR Part 11 ✓ ISO 13485 ✓ ISO 14971

💰 Pricing

$39.00/mo
Free Tier Available

✓ 14-day free trial

Free tier: Up to 3 users

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