QCTest Software

Turnkey Heart Valve Testing QC Software

The ViVitro QCTest program is the only turnkey validated function test software system available. The software is easy to use and can be paired with a specific Function Tester Load Assembly on the ViVitro Pulse Duplicator, for quick valve change-outs.

QCTest operates through a USB Multifunction Measurement and Control Board, compatible with 64-bit operating systems.

 The QCTest software system was developed as a quality control tool for QC heart valve function testing. This production tool enables fast, reliable results for a fraction of the cost of designing and validating an in-house system. QCTest measures valve performance in accordance with regulatory requirements.

QCTest includes security, risk management, simplified user interface, error checking, control steps and standard disposition outputs. QCTest function test software was developed by ViVitro and  meets validation requirements outlined in the FDA General Principles of Software Validation; Final Guidance for Industry, document.

Contact us for more information about how QCTest software or ViVitro’s engineering staff can assist you with Function Testing to meet your Quality Control needs.

 

QCTest Software

  • Step-by-step calibration wizard
  • Error checking verifies calibration and analysis
  • Algorithms automatically analyze data
  • All program activity is logged for security and legacy
  • Reports formatted for production
  • Each operation is verified step-by-step
  • Administrator controls and creates valve disposition criteria, operating acceptance limits, and Tester/Operator access
  • Data is integrated for accuracy, ensuring validated results
  • Meets applicable IEC and ISO software VV&T requirements
  • .Net 3 Platform
  • Configured for 64-bit Windows 7 operating systems
  • Source code created system for completely validated software
  • Certicate of Conformity provided
  • Validation documents are available

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