Regulatory Services
- Ethics Committee Approval – CDSCO/ICMR for Medical Devices
- AERB Approval for Medical Devices
- BIS Registration-Medical Devices
- PC-PNDT Registration Consultancy for Medical Devices
- IP ACT- TRADE MARK / PATENT
- CPCP-PWM/ EWM
- Legal Metrology Registration
- Technical Files (EU) MDR745/ IVDR746
- Risk Assessment for Medical Devices – ISO 14971:2019
- CER, PMS, PMCF, PSUR, SSCP
- EUDAMED Registration Services
- UDI Implementation Guidance
- GMDN and EMDN codes research
- Technical File (TF) Review for MDR 2017/745 & IVDR 2017/746
- Free Sales Certificate (FSC) for Medical Devices & IVDs
- Notified Body Selection & Application Support
