PRODUCT QUALITY MANAGEMENT SYSTEM

Simplexity’s Quality Management System was built for flexibility, addressing your unique needs and distinct requirements for what is needed to ensure a high-quality product. You work in close collaboration with Simplexity’s quality team and engineers to ensure we create a project plan that is both risk-managed and cost-efficient, prioritizing the specific needs of your project.

Aspects of Simplexity’s Quality Management System worth noting:

• Our Certified Quality Management System is audited regularly, both internally and externally by NSF.
• Our Experienced Quality Team helps you define product requirements, perform comprehensive data-based risk analyses, develop design verification strategies, and execute high-quality testing, from product inception through transfer to manufacturing.
• Supplier Management and Performance Tracking activities push risk management upstream to the suppliers, further helping to control and manage project risks.
• Proven Risk Management is practiced and performed in compliance with ISO 14971
• Medical product development is executed in compliance with IEC 60601 and IEC 62304
• Electronic QMS and Client Web Portal provide direct access to project documents for download, review, and approval.
• ISO 13485:2016 Certification. Simplexity has been awarded Quality Management System ISO 13485:2016 certification for Product Design and Development related to medical products. This ISO certification indicates that the company’s quality management system (QMS) meets or exceeds the latest international guidance for medical device product development.

Some relevant Case Study examples:

• Sterifre Medical hired Simplexity to redesign their Aura point-of-care disinfection system in compliance with the ISO 13485 Standard for Medical Device Product Development.
• Simplexity performed a complete redesign of the Natus Medical Light Sensor Calibration System to add functionality, reliability and repeatability.
• Oregon Health and Sciences University and Simplexity collaborated to design an at-home blood sample collection device.

Next Steps: please contact us to see if your project needs match our expertise. Please include as much detail about the issues you are facing as possible, and we will schedule a call to see how we can help.

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