We provide the consultancy in regulatory affairs in the areas of Medical Devices and In-vitro Diagnostic Kits pertaining to the following segments:
- Site and Product Registration
- New Product Approval
- Import registration of Medical Devices and In-vitro Diagnostic Kits
- Free Sale Certificate / GMP Certificate / Market Standing Certificates etc..
- Export Permissions
- Establishing Quality management System (ISO 13485:2016) as per MDR 2017
- Bio-compatibility / Bio-equivalence/ Bio-Availability Studies
- Joint Ventures
- Technology Transfers
- Dossier development & Technical Files as per MDR 2017(Plant Master File & Device Master Files)
