Navigating Compliance, Simplifying Approvals, Ensuring Market Success!

As a Regulatory Affairs and Quality Management professional, I have specialized in global medical device compliance. Implemented risk management processes aligned with ISO 14971:2019, reducing regulatory risks and enhancing product safety. Prepared and submitted CE technical files, MDSAP submissions, and managed regulatory approvals in markets like Ukraine, Russia, and Tanzania. Expert in UDI and GS1 data management, ensuring traceability compliance. Developed clear, regulatory-compliant IFUs and maintained ISO 13485 quality system documentation, supporting product design and development with robust technical file documentation.

Work Terms

I provide end-to-end assistance for CDSCO registration, including documentation, compliance guidance, and application submission. The service covers medical device classifications (A, B, C & D) and regulatory filings under India’s Medical Device Rules (MDR), 2017.
Initial consultation includes a detailed review of your product category, required documents, and regulatory pathway. You must provide accurate and complete information to avoid delays in submission.
ll shared documents and company details will be kept confidential and used only for regulatory purposes. I adhere to strict compliance standards to ensure smooth approvals.