Quality Management
System for
Medical Device

Orcanos QMS software delivers a comprehensive cloud-based quality management system that guarantees your products surpass regulatory compliance standards, including ISO 13485, 21 CFR Part 820, and supports GMP.

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Accelerate your process to achieve
ISO 13485 compliance

Orcanos QMS software provides a centralized platform to control all quality processes. This eliminates the need for a paper-based quality system and enables organizations to comply with strict FDA regulations and established ISO quality standards.

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What makes Orcanos stand out?


Integrate Design Control (ALM) with Quality Management System and regulation to establish a centralized repository.

Document Generator

Effortlessly generate submission-ready documents (in Word or Excel) that conform to your company's templates.

Integrated Risk Management

Integrating risk management into the development process and quality events helps prevent potential hazards and failures while following ISO 14971 guidelines.

21 CFR Part 11 Compliance

Orcanos supports electronic records and electronic signatures in compliance with 21 CFR Part 11/Annex 11.

Dashboards And Analytics

Keep track of projects and the status of quality procedures with detailed reports and charts through our customized dashboards.

Easy Customization

Our platform offers powerful customization tools to tailor your quality forms, e-sign processes, status flows, mandatory rules, and permissions to your specific needs and your company's Standard Operating Procedures.

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