Untangle Medical Device Development with Design Control Software
QT9 Software
QT9 brings quality and business processes together in easy-to-use QMS and ERP platforms. Share data across operations.
Medical device creators and manufacturers have a lot on their plate. Not only are they creating potentially life-altering equipment, they are working in an industry where safety and attention to detail are paramount.
In 2023, one of the greatest number of U.S. Food and Drug Administration (FDA) warning letters issued for medical devices related to deficiencies in design controls. Design control software can help you avoid potentially costly mistakes that result from inadequate design controls, incorporating all the elements you need to not only successfully meet design control requirements, but create efficiencies that save time and money.
This article provides an overview of design control software and the best practices for creating an effective and value-added design control environment.
Director of Operations, QT9 Software Ltd
6 个月Great article! Design control is a critical process in medical devices, and it relies on linkages and traceability to show a complete "story" of the medical device. This article distills the design process into the key elements and showcases how QT9 can help keep all the data aligned and meeting regulatory requirements... thus reducing the onerous aspects of design control!