Needless to say, in case of medical devices, patient safety is of utmost importance. Hence, medical device manufacturing process regulatory compliance is vital to ensure the device is safe and will perform as intended. However, worker safety is an equally important...
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...
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...
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...
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...