R&Q's Blog

Medical device industry news and trends - and the resources to understand and act on them.

 

Navigating Substantial Equivalence

Part of the mission of the CDRH is to ensure medical devices are safe and effective. Based on the risk of the device and the agency’s familiarity with the device type, different levels of evidence are required to convince the FDA that a device is safe and effective.

Eureka!

Eureka! A light bulb goes off, and suddenly you’ve invented a great new medical device that will save millions of lives worldwide every year.

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