Circular on Testing and Evaluation of Medical Devices and IVDs

by Sudhriti M | Sep 6, 2024 | Medical Device

Rigorous testing and evaluation of medical devices and IVDs is necessary to protect the public health. Medical devices and IVDs have a pivotal role in diagnosis and treatment of diseases and various medical conditions. Hence, regulatory officials have to ensure only...

5 Quick Tips on How to Reduce Downtime in Pharma Industry

by Sudhriti M | Aug 30, 2024 | Pharmaceutical

In this blog, we have discussed why pharma companies should pay special attention to downtime, especially unplanned downtime.Additionally, we have provided some tips for reducing downtime in pharma industry. What is downtime? To reduce downtime in pharma industry, it...

Clean Room for Medical Device Manufacturing Factory: A Guide

by Sudhriti M | Aug 19, 2024 | Medical Device

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,...

CDSCO IVD Classification: Everything You Need to Know

by Sudhriti M | Aug 19, 2024 | Medical Device

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...

In Process Quality Control: IPQC in Pharmaceutical Industry

by Sudhriti M | Aug 8, 2024 | Pharmaceutical

Pharma companies are required to prevent substandard pharmaceuticals from entering the market. Thus, drugs have to be tested for efficacy, quality, and safety. Additionally, regulatory bodies require pharma companies to test the drugs manufactured for identity,...