Medical Devices Testing and Automation

Services4

Testing and automation of medical devices for 2 of world’s top 10 global medical technology companies helping them achieve FDA compliance and adherence to industry standard protocols such as DICOM and IGS.

Some of the features tested are listed below:

  • Surgical Imaging System, Navigation System
  • Imaging modes (2D, 3D), DOSE Reporting, X-Ray
  • Patient Database Management
  • DICOM (Digital Imaging and Communications in Medicine) protocol adherence
  • FDA QA regulations and standards compliance
  • GUI and Rebranding Testing
  • Medical Alert & Personal Emergency Response System
  • PEGA & Genesys based case & contact center solution
  • End to end transfer of HL7 messages from one system to another
  • Vision measurement Optotypes accuracy testing using lenscope
  • Testing Acuity, Amsler, DigiGrid, Inverse Contrast, Inverse Acuity, Low Light Contrast, Contrast, Acuity + Contrast, Red Blue Acuity, Low Light Acuity vision tests
  • Automated QA management software for devices VersaHD, Clinac, Trilogy and many more

Validated Tools

  • Derived non-functional requirements from FDA standards
  • Ensured automation and simulation tool complies to the non-functional requirements

Automated

  • Localization support for English, French, Dutch, Italian, German, Spanish and Russian
  • GUI and functional regression and integration with LabVIEW Sequencer
  • Client application performance based on database volumes

Developed Medical Device Simulator

  • For testing and training as an alternative to physical devices
  • Surgical Imaging and Stealth System Simulator based on IGS protocol
  • Medical alert and Personal Emergency Response System Simulator based on XMPP Protocol

Tools Used

  • SmartBear TestComplete for Automation
  • LabVIEW Sequencer
  • DVTk for DICOM Testing
  • Neotys NeoLoad, Empirix Hammer
  • HAPIE