RQM+ Medical Device and In Vitro Diagnostic Blog

on 24 August 2016 | By Nancy Morrison, RQM+

It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, 2016 it finally happened! For those of you who remember the FDA's attempt...

on 13 June 2016 | By Carol Vierling

You've already read a few benefits in the title but let's reiterate: Earn RAC points Enhance your resume/LinkedIn profile Get published, and share your expertise with industry peers in the process These are just three of the several reasons you should consider writing an article...

on 14 January 2013 | By Ryan Kasun

A few quick notes I wanted to post while clearing my inbox of my "informative reading" emails from last week:

on 26 September 2012 | By Ryan Kasun

I think it's high time we start profiling a few applications that have been approved for use by the FDA, discuss their functionality, and potentially profile the impending issues they may encounter.