Other Services

Other Services

(European Union MDR, IVDR, US FDA, MD SAP, TGA Australia, CDSCO-India & other) #

  1. Technical File creation / Dossier creation & remediation
  2. Post Market surveillance Plan & reporting
  3. Adverse event reporting to USFDA / EU
  4. Authorized Agent in India /Europe
  5. General Safety performance checklist
  6. Performance evaluation report for IVDR
  7. Registration Number for Non-Notified Medical Devices in India
  8.  Guidance & solutions for Medical Devices manufacturers and startups
  9. Permission to Manufacture all classes of Medical & Diagnostic devices.
  1. Label compliance EU / FDA / CDSCO
  2. Registration Number for Non-Notified In Vitro Diagnostic
  3. Label Compliance for IVD
  4. Free Sale Certificate in India.
  5. Permission for test license to manufacturers.
  6. And many more customized services for Medical Devices & Diagnostic devices companies in India and out of country.
  7. We are giving complete hand-holding technical &regulatory support to startups to place their product in the Indian & global markets.

( # MDR – Medical Devices Regulation, IVDR- in vitro diagnostic medical devices, US FDA – United States Food and Drug Administration, MD SAP-Medical Device Single Audit Program, TGA- Therapeutic Goods Administration, CDSCO-Central Drug Standard Control Organization )

Our broad range of skills and services provides a one-stop shop for businesses in Medical Devices and Diagnostic Devices