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.
Product teams all have the same goal: produce high-quality products and reduce time to market. Achieving these goals simultaneously can be difficult, but your team doesn’t have to sacrifice one for the other. Learn how in this eBook.What You Will Learn In this eBook,...
Key Takeaways AI adoption alone does not prove ROI. Teams must measure how AI coding tools impact development speed, software quality, engineering capacity, and overall costs. Developer time saved must translate into business value. Tracking recovered hours,...
Key Takeaways Consultants, professional services, and managed services serve different purposes. Consultants provide strategic guidance, professional services focus on implementation, and managed services support ongoing operations. Forward Deployed Engineers (FDEs)...
Challenges Increased market demands and need for real-time global collaboration Insufficient Product Data Management (PDM) system for the scale and complexity of operations Need to translate a single EBOM into accurate MBOMs across global locations Increasingly...