MEDICAL DEVICES

Expertise in submissions for multiple medical devices and managed different compliance activities to (EU) MDR 2017/745 and IVDR, USFDA 510(K), 513 (g), 501(k), MDUFMA, and ISO standards among other international market authorizations of products

FWQRC shall assist you for the following activities

  1. Classification of medical devices
  2. Identifying the appropriate pre-market submission pathway
  3. Review of pre clinical & clinical trial data
  4. Compilation and Review of  PMA, PMN, HDE applications in the specified formats by ensuring compliance with regulations pertaining to respective Health Authorities
  5. Submission of application with relevant regulators to register the establishment & list the device
  6. Post market regulations & processes : Monitoring & reporting patient incidents, involving the device, both to the manufacturer & to the FDA