Case Studies
Regulatory Setup for Refurbished Medical Devices
Problem Statement: A Mumbai-based company sought to establish a process for importing and refurbishing medical devices such as CT Scans,
STPI Registration for an IT and Digital Health Company
Problem Statement: A Bangalore-based IT and digital health company exporting software services through cloud platforms like AWS and Microsoft Azure
510(k) Submission for ECG Analysis and Interpretation Software (SaMD)
A client approached D2R Global Consulting with their ECG analysis and interpretation software, a Class II SaMD, seeking 510(k) clearance
CDSCO Import License for Urethra Catheter
A healthcare company specializing in innovative medical devices sought to import its Urethra Catheter, designed to minimize iatrogenic urethral injuries,
CDSCO Manufacturing License for Neonatal Baby Warmer
A Chennai-based medical device company sought a CDSCO manufacturing license for their newly developed Baby Warmer (CIC 101). The device,
CE Certification for Surgical Dressing product
The Indian branch of a MNC medical device manufacturer sought CE certification for Scrofalon®, a sterile absorbable haemostatic gelatin sponge,
