Quality Engineering

Quality engineering is fundamental to delivering client satisfaction. Today’s fast-moving, multidisciplinary products frequently involve complex interactions and timely problem-solving. Every new product that is designed has distinct requirements, and Simplexity’s quality engineering processes have been built to enable close collaboration with our clients to create a product plan that is both risk-managed and cost-efficient, prioritizing the specific needs of the project.

Simplexity’s Quality Engineering Expertise Includes:

• Requirements definition and specification documentation  
• Verification activities including test protocols, and test reports from product inception through transfer to manufacturing including: 
  • Engineering Confidence Testing (ECT) builds and testing
  • Design Verification Testing with pre-production builds
  • Reliability testing
  • Regulatory testing
• Proven Risk Management, performing comprehensive, data-based risk analyses in compliance with ISO 14971  
• Managing to Simplexity’s Certified Quality Management System which is audited regularly, both internally and externally by NSF.  
• Supplier Management and Performance Tracking activities ensure that risk management is also handled upstream by the suppliers, further helping to control and manage project risks.  
• Software and Firmware Development in compliance with IEC 62304. 
• Medical device development to meet and test against IEC 60601 safety standards. 
• Electronic QMS and Client Web Portal communication to provide direct client 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.  
• Analysis of data on quality system effectiveness, supporting continued improvement to our internal quality goals and objectives. 

Read more about Simplexity's ISO 13485:2016 certified compliant quality management system

With a constant eye toward meeting client, product, and regulatory requirements, as well as driving continuous improvements to our internal processes, our quality engineering team is the hub that keeps product development at a high standard from concept through production.

 

CASE STUDY: ANAVASI DIAGNOSTICS MOLECULAR DETECTOR

 

CASE STUDY: REPERIO HEALTH

 

CASE STUDY: STERIFRE AURA