Compliant Solutions Tailored to Your Industry
At Quality System Modelers, our product offerings are meticulously designed to align with the U.S. and EU regulations and the applicable ISO standards for each manufacturing category. We provide comprehensive Product Packets that cater to a broad spectrum of industries within the medical device manufacturing sectors. Each packet may include any combination of individual models, tools, guidance, frameworks, and/or methodologies to create, enhance, or mitigate your Quality Management System (QMS).
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Industry-Specific Solutions
Our solutions are segmented to meet the precise needs of:
- Medical Device Manufacturing
- Class I
- Class II, IIa, IIb
- Class III
- In Vitro Diagnostic Devices (IVD)
Coming Soon!
Pharmaceutical Manufacturers
Vaccine, Blood, and Biologic Manufacturing
Combination Drug/Device Manufacturing
Our Offerings
Quality System Modelers allows you to specify your unique requirements, enabling the purchase of any combination of the following, tailored to your specific needs:
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.
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.
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Contact Us
Ready for a Conversation? Schedule a meeting with our team. Let's discuss your needs and find the best solutions for your Quality compliance challenges.