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...
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...
Recent Reminder for CDSCO License Retention Fee Payment
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...