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™ ISO Management Software is a one stop ISO 13485 solution. QT9™ is completely 21 CFR Part 11 compliant with electronic signatures and is validated after every release. Let QT9™ handle the burden of your ISO 13485 requirements and automate your management system making your organization more efficient and productive.