Implantable medical devices are surgically or medically introduced entirely or partially into the human body. They are intended to remain there after the procedure. These specialized devices serve critical medical purposes, such as supporting, replacing, or augmenting...
A thermometer provides a quick, non-invasive, and reliable way to measure body temperature, which is an indicator of health status. By detecting fever, hypothermia, or abnormal fluctuations, thermometers help clinicians and patients identify infections, monitor...
In India, Central Drugs Standard Control Organization (CDSCO) stringently regulates Software as a Medical Device (SaMD). Therefore, securing the CDSCO SaMD license is a mandatory requirement for marketing your product in India. Owing to its increased...
CDSCO medical device QMS is a strategic framework that ensures patient safety, operational discipline, and market access. Preparing one effectively means going beyond documentation. Manufacturers should treat the QMS as a living system. It should be continuously...
To perform a clinical investigation in India, securing permission from the CDSCO is non-negotiable. A detailed study protocol has to be developed keeping patient safety in mind. The clinical investigation plan should comply with the ethical principles and applicable...