Quality System Modelers: Simplifying Quality Management
Exceptional systems require solid foundations!
At Quality System Modelers (QSM), we are revolutionizing the way medical device manufacturers achieve and maintain compliance. Our suite of industry-specific models, tools, guidance, frameworks, and methodologies ensures that your Quality Management System (QMS) is not only compliant with U.S. FDA regulations, European MDR/IVDR, and ISO standards but is also tailored to your unique operational needs.
What Makes Us Different?
Customizable Solutions
With QSM, you're in control. Choose only the components you need, avoiding unnecessary costs on subsystems that don't serve your specific requirements. Whether you need to implement a new QMS, streamline your current complaint handling process, or integrate a new CAPA system, we provide turnkey systems designed for flexibility and ease of implementation.
Streamlined Compliance
Our products are designed for precision and efficiency, preparing you for regulatory or notified body inspections and certificate issuing body audits. Our approach minimizes the hassle, transforming complex compliance requirements into manageable tasks from a bird's eye view down.
Tailored Support
You can purchase only the elements necessary for continuous improvement or to implement necessary remediations for nonconformances. We also offer up to 20 free Customer Service hours with any purchase, providing expert advice and assistance to ensure seamless integration of our components into your processes.
Our Offerings
QMS Models
Process flowcharts with recommended steps that can be used to identify necessary steps for use in gap analyses and internal audits.
QMS Tools
Templates for Policies, Procedures, Work Instructions, and Forms with suggested content so you don't have to start with a blank slate.
Frameworks
Checklists that cover all subsystems of the regulations and can be used for internal auditing and to ensure your processes are not missing any elements.
Offerings Coming Soon!
Guidance
Step-by-step instructions for implementing QMS subsystems and addressing nonconformances issued by external entities
Methodologies
Strategies / Training for implementing continuous improvement techniques and addressing nonconformances within your existing QMS.
Ready to Transform Your QMS?
Discover our solutions and start your journey to simplified compliance and operational excellence. At Quality System Modelers, we're not just a QMS system provider; we're your partner in quality management.