Last week, SolidWorks held its annual conference, SolidWorks World 2018, in Los Angeles where over 5,000 engineers, manufacturers, educators and enthusiasts attended. Many who could not attend streamed the conference sessions online and scanned the 5000+ tweets that...
Product lifecycle management (PLM) systems have evolved from being custom-built, on-premise applications to cloud-based, off-the-shelf solutions. As adoption for PLM in the cloud increases, system validation approaches in FDA/GXP regulated industries have had to...
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
Improve Your Ability to Sell Software into Medical Device Companies – In this paper we will share five things you can do to make your software application more attractive to medical device companies.
Avoiding 21 C.F.R. §820.70(i) FDA Warning Letters
