R&Q's Blog

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

 

Mobile Medical Applications - Most Reliable Apps, Internationally?

A few notable posts pertaining to mobile medical applications came through my Twitter feed / Inbox recently, so I wanted to share!

Setting Precedence

I sat down tonight, as I do every night that I write a blog post, and I started reading the prior posts from my colleagues. I had every intention of writing on a different topic tonight, but something struck a chord with me when I looked through the blogs. They all had something in common. It’s something that we as regulatory and quality folks struggle with and love at the same time. It’s the topic of precedence.

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.

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