Notified and Non-Notified Medical Devices: Key Differences
In this blog, we have focused on the differences between notified and non-notified medical devices in India. Additionally, we have provided an overview of the different regulatory processes for different categories of medical devices. Furthermore, we have touched upon...
Clean Room for Medical Device Manufacturing Factory: A Guide
Clean rooms are crucial for manufacturing industries where product quality is easily affected by factors, such as airborne particles. Thus, clean rooms are pivotal in a medical device manufacturing industry. Medical device quality affects the patient outcome. Hence,...
Designing and Manufacturing Implantable Medical Devices
Advances in biomedical engineering and medical electronics have led to the development of implantable medical devices. These devices are implanted in the human body for improving the patient’s quality of life. Over the past few decades, implantable medical devices...
CDSCO IVD Classification: Everything You Need to Know
In-vitro diagnostic devices are instruments, reagents, or systems intended to diagnose a disease or other health conditions. IVD tests are usually performed in test tubes and similar equipment outside the body. Moreover, the tests can be performed using various...