Helian
Durham, United States (US) · Health and Medical
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Last verified
May 2026
Helian is an AI-powered Quality Management System provider based in Durham, North Carolina, specializing in supporting early-stage medical device companies.We help medical device manufacturers achieve and maintain compliance with critical regulations like ISO 13485 and FDA 21 CFR Part 820, significantly reducing the time and cost associated with quality management.
Overview
We help medical device manufacturers achieve and maintain compliance with critical regulations like ISO 13485 and FDA 21 CFR Part 820, significantly reducing the time and cost associated with quality management. Our platform streamlines processes, providing a modern and intuitive QMS experience.
Helian’s AI-driven approach offers a unique solution for early-stage companies with limited budgets, delivering a powerful quality management system without compromising on compliance or innovation. We are dedicated to accelerating the development and launch of life-saving medical devices.
Helian is committed to providing a user-friendly interface that requires minimal training, empowering your entire team to contribute to a robust and compliant quality management system.
Contact Details
Durham, United States (US)
Company Type
Private Limited Company
Employees
2-10
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