5 Pro tips for Hassle-Free US FDA 510(k) Submission

by Sudhriti M | Oct 30, 2024 | Medical Device

Compliance with US FDA regulations is mandatory for marketing and distributing medical devices in the U.S. The FDA 510(k) is a premarket submission process used to determine whether the medical device is safe and effective. Owing to incorrect application, thousands of...

Using Artificial Intelligence in Medical Devices Industry

by Sudhriti M | Sep 19, 2024 | Medical Device

Artificial intelligence is a powerful and disruptive domain in the field of computer science. It empowers machines with the ability to perform tasks that usually require human intelligence. Furthermore, artificial intelligence (AI) enabled-machines match or improve...

Recent Reminder for CDSCO License Retention Fee Payment

by Sudhriti M | Sep 14, 2024 | Medical Device

CDSCO license for medical devices manufacture/import and registration certificates for QMS medical device testing labs are valid indefinitely. All licenses, Form MD-5, Form MD-6, Form MD-9, Form MD-10, and Form MD-15, are issued for an indefinite period. The validity...

Capital Subsidy for Domestic Medtech Component Production

by Sudhriti M | Sep 14, 2024 | Medical Device

In addition to fulfilling its own demands, India caters to a considerable portion of the world’s needs for generic medicines and low-cost vaccines. Hence, it has earned the name “pharmacy of the world”. However, when it comes to medical devices, India’s medical device...

Clean Room Validation According to ISO 14644 Guidelines

by Sudhriti M | Sep 14, 2024 | Medical Device

Clean rooms have a vital role in the medical device manufacturing industry. In the medical device industry, product quality is easily affected by factors, such as airborne particles. Hence, clean rooms are required to maintain a sterile and clean environment....