US FDA 510(k) Dossier Preparation: Everything You Need to Know
510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) for Class I, II, and III medical devices. This premarket submission is used to demonstrate evidence of substantial equivalence. The process is...
5 Pro tips for Hassle-Free US FDA 510(k) Submission
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...
Everything You Need to Know About CDSCO MD7 and MD9
The Central Drugs Standard Control Organization (CDSCO) regulates and controls medical devices entering the Indian market. Hence, medical device manufacturers will have to secure the CDSCO medical device manufacturing license to manufacture medical devices in India....
Using Artificial Intelligence in Medical Devices Industry
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...