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
MEDICAL DEVICES
FWQRC shall assist you for the following activities
- Classification of medical devices
- Identifying the appropriate pre-market submission pathway
- Review of pre clinical & clinical trial data
- Compilation and Review of PMA, PMN, HDE applications in the specified formats by ensuring compliance with regulations pertaining to respective Health Authorities
- Submission of application with relevant regulators to register the establishment & list the device
- Post market regulations & processes : Monitoring & reporting patient incidents, involving the device, both to the manufacturer & to the FDA
