Upgrade your paper-based or generic QMS to a modern, cloud-based solution that enables you to track quality events, trace design controls to risk, ensure compliance, and more.
Our QMS software helps you bring medical devices to market faster and keeps them on the market longer.
Ensure compliance from the start without lifting a finger. Your software comes aligned with 21 CFR Part 820, ISO 14971:2019, ISO 13485:2016, and FDA requirements.
Enhance team collaboration, break down information silos, and maintain a single source of truth. By reducing risk of noncompliance, your device can stay on the market longer.
Create a culture of quality from idea, to development, to post-market surveillance under one connected system.
Spend less time digging through spreadsheets and binders with every auditor request. With one interconnected, living database, you can get through audits with fewer issues in just a few clicks.