Medical Devices

Rapid advancements in technology and medicine continue to redefine the healthcare industry. Medical and analytical device manufacturers, healthcare professionals, and legal and regulatory communities constantly strive to keep up with these changes without compromising their ability to deliver and / or ensure product safety and performance. Continuous changes in regulatory standards and the need to adopt cutting-edge technologies are making medical and analytical device manufacturers come up with new features in their EDC packages and upgrades to their hardware platforms.

ValueLabs provides end-to-end solutions to EDC components of the following systems:


  • Medical devices
  • Clinical diagnostics
  • Microarrays
  • Hematology analyzers
  • Analytical instruments

We also provide services for the Testing and Validation of devices before they can be marketed. Our state-of-the-art wet Labs help our clients with a dry run before implementing a solution.

Solutions


  • Product development
  • Device driver development
  • Product maintenance
  • Product integration
  • Testing / Test automation
  • Platform migration
  • Web / Mobile-based applications for Device configuration and Diagnostics
  • Lab Computing services
  • Compliance and Validation services
    • HL7 for seamless integration
    • DICOM – for medical images
    • 21 CFR part II
    • FDA 820
    • GxP service

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