About Quality System Modelers
Founded in 2023, Quality System Modelers, LLC (QSM) is at the forefront of simplifying quality management for the medical device manufacturing industry. Our mission is to deliver straightforward, cost-efficient solutions for developing, updating, or remediating Quality Management Systems (QMS) and related subsystems. Tailored to the unique needs of each organization, we bridge the gap between regulatory compliance and operational excellence.
Guiding Principles
Our commitment is to offer industry-specific models, tools, guidance, frameworks, and methodologies at a cost significantly lower than our competitors. We believe in making quality management accessible and manageable for organizations of all sizes.
Our Vision
We aim to collaborate closely with our clients, developing robust QMS infrastructures that not only meet but exceed all regulatory requirements and customer expectations. Our vision is to be the partner of choice for companies seeking to establish or elevate their quality management practices.
Our Mission
To equip our clients with the infrastructure needed to establish, enhance, or overhaul their Quality Management Systems, ensuring a foundation of quality that supports their long-term success.
Quality Policy
We are dedicated to providing the most straightforward, standardized QMS solutions to our clients in the medical device, pharmaceutical, and biologic sectors. Our focus is on delivering these services at the lowest possible cost while ensuring full compliance with all relevant regulations, standards, and guidance documents.
Our Foundation
Quality System Modelers is proud to be an LLC Corporation, incorporated in California, founded on a mixed matrix organizational structure. At our core is Devin, our visionary and primary decision-maker, supported by a team of personnel and associates committed to realizing his vision through shared goals and objectives.
Devin I. McElroy, M.B.A
Devin brings a wealth of experience from the medical device, pharmaceutical, and biologics manufacturing industries. With an impressive array of national and international certifications and educational background, they have been instrumental in helping him to develop technological solutions that enhance quality system and manufacturing methods.
Devin's education includes a Bachelor of Science in Business / Information Systems and an M.B.A in Technology Management. The primary international certifications include Lead Auditor (for ISO 13485 and for ISO 9001), Six Sigma Green Belt, and Manager of Quality / Organizational Excellence.
Known for his leadership in Operational Excellence and his collaborative approach with regulatory agencies, Devin embodies the spirit of innovation and efficiency that drives QSM.
Professional Relationships
Our Promise
At Quality System Modelers, we are more than just a service provider; we are a partner in your quality management journey. Our turnkey solutions are designed to be seamlessly integrated into your business, enabling you to focus on what you do best. With QSM LLC, you're not just complying with standards; you're setting them.
