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...
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