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Medical Devices

Medical Devices

Launch and scale your medical devices in India, the US, and Europe with end-to-end regulatory execution—not guesswork. From regulatory strategy, gap assessment, plant set-up and QMS certification to audit preparation, training, testing, and documentation, we build a clean, inspection-ready pathway for your portfolio. Our team navigates CDSCO, US FDA, and EU MDR so you can focus on innovation, not forms.

We handle the full lifecycle of approvals and licenses, including CDSCO MD-42 distribution/wholesale licenses, test licenses, manufacturing and loan licenses, import licenses, Free Sales, Market Standing, Non-Conviction and Neutral Code certificates, plus US FDA registration & listing, small business determination, CFG, 510(k) premarket clearance, and EU MDR self-registration and CE marking. Whether you are a startup or a global OEM, you get a single expert partner for clearances, permissions, and ongoing compliance.

  • MD-42 Distribution/Wholesale License
  • Test License
  • Manufacturing License MD3/5 or MD7/9
  • Loan License MD4/6/8/10
  • Import License MD14/15
  • Free Sales Certificate
  • Market Standing Certificate
  • Non-Conviction Certificate
  • Neutral Code
  • QMS Certification
  • Registration & Listing
  • Small Business Determination
  • CFG - Certificate for Government
  • 510(k) Premarket Clearance
  • Self Registration
  • CE Marking

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