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QT9™ QMS ISO 13485 Software Compliance

ISO 13485 is the quality standard designed for medical device manufacturers. ISO 13485 is also an international standard that is commonly used as the basis of regulatory compliance for the FDA. If you are a medical device manufacturer, BioMed/Pharma, or perform work with medical device manufacturing or distribution, ISO 13485 is an essential quality standard for your organization.

QT9™ QMS Quality Management Software is a one stop ISO 13485 software solution. QT9™ QMS is completely 21 CFR Part 11 compliant with electronic signatures and is validated after every release. QT9™ QMS is in line with the FDA QSRs to not only keep you in compliance with ISO 13485, but also FDA quality system requirements. Let QT9™ QMS handle the burden of your ISO 13485 requirements and automate your management system making your organization more efficient and productive.

Are you regulated by the FDA? Ask us about our validation program!

Look below to see how QT9™ QMS stacks up against the ISO 13485:2016 standard.

ISO Requirement QT9™ QMS Module/Solution
Element 4.2.4 - Control of Documents QT9™ QMS Document Control Module
Element 5.6 - Management Review Requirements QT9™ QMS Management Review Module
Element 6.2.2 - Employee Training QT9™ QMS Training Module
Element 6.3 - Infrastructure QT9™ QMS Preventive Maintenance Module
Element 7.1 - Risk Management QT9™ QMS FMEA Module/QT9™ QMS Risk Assessments Module
Element 7.3 - Design & Development QT9™ QMS ECR/ECN Module
Element 7.4.1 - Purchasing/Evaluation of Suppliers QT9™ QMS Supplier Evaluation Module/QT9™ QMS Supplier Surveys Module/QT9™ QMS Corrective Action Module
Element 7.5 - Control of Production and Service Provision QT9™ QMS Inspections Module
Element 7.6 - Control of Monitoring and Measuring Devices QT9™ QMS Calibration Module
Element 8.2.1 - Customer Feedback System QT9™ QMS Customer Feedback (Customer Complaints) Module
Element 8.2.4 - Internal Audit QT9™ QMS Audit Management Module
Element 8.3 - Control of Nonconforming Product QT9™ QMS Nonconforming Product Module/QT9™ QMS Corrective Action Module
Element 8.5.2 - Corrective Action QT9™ QMS Corrective Action Module
Element 8.5.3 - Preventive Action QT9™ QMS Preventive Action Module