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.
As the shift to cloud-based CAD increases, businesses are searching for the perfect virtual CAD tool. Discover all about SPK vCAD as well as other virtual CAD options for collaborative design on this eBook.What You Will Learn In this eBook, you will discover: Future...
As the shift to cloud-based CAD increases, businesses are searching for the perfect virtual CAD tool. Discover all about SPK vCAD as well as other virtual CAD options for collaborative design on this eBook.What You Will Learn In this eBook, you will discover: Future...
In this episode of All About Accelerating Products, we chat with Vish Reddy, co-founder of Revyz, a secure backup and data audit solution built for Atlassian cloud products. Vish walks us through the moment that sparked it all and how that frustrating experience led...
Quality is a necessity in every industry, but it is especially vital to automotive designers and manufacturers. This is evident by the strict automotive quality standards manufacturers must meet to achieve customer expectations and ensure safety. Two critical...