Medical Device Quality Assurance

Elevate the Quality of Your Devices and Products

Quality assurance (QA) departments are required to manage the compliance of government regulations and maintain production costs to ensure quality and patient safety. QA professionals oversee operations so products meet current Good Manufacturing Practices (cGMP) and internal standards. They are also responsible for training, audits, documentation, and communication to leadership.
Sparta quality management software helps QA professionals to achieve compliance, increase efficiencies, improve quality, and reduce costs.  It centralizes and integrates key quality processes globally, including management and reporting of deviations, complaint handling, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), and others.  

Benefits of Sparta QMS Software for Quality Assurance

  • Ensures compliance with 21 CFR Part 11, as well as other government regulations and ISO standards. 
  • Implements best-of-breed quality management integrated with your ERP and MES systems. 
  • Reduces the risk of adverse events and other customer incidents.
  • Maintains high quality levels across the supply chain.
  • Reduces costs incurred by inefficient operations, re-works, scrap, and process down times.  
  • Decreases product approval and time-to-market cycles.

Quality Assurance Processes

Ensure compliance, improve quality, and reduce costs by centralizing and integrating quality processes, including management and reporting.


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