7 Commonly Used Medical Device Sterilization Methods: A Guide

by Sudhriti M | Jun 6, 2024 | Medical Device

While using medical devices to diagnose, monitor, and treat patients, they come in direct contact with patients. They may be used externally or internally. Thus, proper sterilization of medical devices is necessary to reduce chances of infection caused by these...

Technology Transfer in Medical Devices: The What and Why

by Sudhriti M | Jun 4, 2024 | Medical Device

The Indian medical devices industry is dynamic and evolving. India is witnessing an increasing demand for technologically advanced novel medical devices. Technology transfer increases local production, thereby increasing access to advanced medical devices. Medical...

SaMD and SiMD: The Differences and Applicable Regulations

by Sudhriti M | Jun 3, 2024 | Medical Device

New-age technology and software are revolutionizing healthcare. Currently, software is being used to monitor, diagnose, prevent, manage, and even treat diseases. Software used in healthcare industry are available in different types and forms.  The two main categories...

CDSCO License Retention Fee: Mandatory for License Validity

by Sudhriti M | Jun 2, 2024 | Medical Device, Medical Device License Requirements

In a recent circular, dated 15.5.24, CDSCO has issued a reminder for license or registration retention under MDR, 2017. This reminder for license and registration certificate renewal requirements is intended for medical device manufacturers, importers, and testing...

Medical Device Process Validation Assures the Device Quality

by Sudhriti M | Jun 1, 2024 | Medical Device

Regulatory bodies require medical device manufacturers to confirm whether the finished product meets the set regulatory benchmark. Manufacturers need to have strict quality control systems to ensure the devices being manufactured comply with safety and quality...