Medical Devices Testing and Automation

Services4

Testing and automation of medical devices for 2 of the 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