Problem Statement:

A Chennai-based medical device company sought a CDSCO manufacturing license for their newly developed Baby Warmer (CIC 101). The device, designed as a sophisticated neonatal open care system, required compliance with Medical Device Rules, 2017, to meet regulatory requirements for manufacturing in India. The process included aligning with quality standards, preparing for regulatory submissions, and passing site inspections.

Our Solution:

1. Regulatory Documentation:
   D2R prepared the complete documentation package, including the Device Master File (DMF) and Risk Management File (RMF), ensuring all requirements under ISO 13485 were met.
2. Facility Readiness:
   Conducted a thorough gap analysis of the manufacturing facility and implemented necessary corrective actions, including cleanroom validation, equipment calibration, and personnel training, to align with CDSCO standards.
3. Inspection Support:
   Facilitated Form MD-5 submission and coordinated with CDSCO for the site inspection. Provided on-site support to address queries and ensured smooth completion of the inspection process.
4. End-to-End Guidance:
   D2R offered continuous support throughout the regulatory journey, from submission to final approval, ensuring compliance with all manufacturing and safety standards.

Outcome:

The company successfully obtained the CDSCO manufacturing license for the neonatal baby warmer, enabling them to commence production in compliance with regulatory requirements. This achievement positions the company to deliver their innovative product to meet critical neonatal care demands in India and globally.