CDSCO Registration for Organ Preservation Solution: A Guide
CDSCO registration is needed to prevent spurious inferior quality medical devices from entering the Indian health care market. In this blog, we will focus on organ preservation solution that has been designated as a medical device by the CDSCO. We will delve into the...
New Opportunities in the Medical Devices Manufacturing Segment
The Indian medical device industry is witnessing a double-digit growth rate. It is one of the top 20 markets in the world and the 4th largest in Asia. Moreover, the Indian medical device market size is approximately $ 11 bn. Infrastructural upgrades and increasing...
Materials Used for Manufacturing Medical Devices: A Guide
When manufacturing medical devices, safety, regulatory compliance, performance, and resilience are the major factors to focus on. Furthermore, while choosing medical device manufacturing materials, biocompatibility, durability, and regulatory compliance are some of...
ISO 13485 Certification for Class A and B Medical Devices
In the medical device industry, safety and quality are non-negotiable. Hence, various regulatory guidelines govern the medical device industry to ensure high-quality, safe, and effective devices are being manufactured. One such guideline is ISO 13485 standards. ISO...