The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.
We invite you to download our paper on the topic of 483 Observations.
Do you know the full cost and benefits of moving your .NET application to the cloud? In this guide we’ll cover everything you need to know about your .NET cloud migration. Is this guide for you? If you’re faced with outdated legacy systems and the pressures of digital...
Considering the leap to cloud-based CAD and PDM solutions? A move to platforms like SolidWorks 3D CAD in the cloud paves the way for unmatched flexibility. Imagine accessing intricate engineering data from anywhere at any time. And, the benefits don’t end there. In...
Protecting your business against the latest cybersecurity threats isn't easy, is it? Today, cyber threats are becoming more sophisticated, and they're targeting a broadening field of potential victims. Consequently, businesses are feeling the pinch with increasing...
On Monday, September 18th, Atlassian announced it would be slightly increasing prices for its Cloud products and setting limits on the automation rules per type of paid cloud plan. Here’s a quick summary of the Atlassian Cloud price changes due to take effect October...
