Hundreds of medical device manufacturers have automated quality and compliance with QT9's highly rated Quality Management System (QMS). Our user-friendly interface and no-nonsense licensing lets medical device companies large and small focus on creating quality, life-changing products. QT9 QMS can satisfy all compliance needs for medical device manufacturers, including ISO 13485, 21 CFR Part 11, & 21 CFR Part 820 (GMP), and give your teams the documents and data they need in one, fully validated source of truth.
Whether it is integrating customer complaints to nonconformances, deviations to engineering change, or even document approvals to employee training, QT9 QMS can automate any medical device manufacturer’s quality needs keeping them prepared and ready for any ISO, FDA, or customer audit.