Our Services

  • We will Consult you on the documentation front for ISO 13485 and get you Certified by an appropriate accreditated Body.

  • Don’t know what standards apply to the device? and where to get it tested? we help you get it done.

  • Whether it’s CE, FDA, or CDSCO, we help you get the certification done. Contact for more info.

  • We will consult you on all the necessary documentation related to Testing or Certification such as

    • Risk Management file

    • Usability File

    • CE/FDA/CDSCO Technical File or Device File

    • ISO 13485 Documentation

  • We will advise on Compliance related issues for your device.