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.
GitLab’s Duo Agent Platform is a new tool enabling government agencies to securely harness AI capabilities. Explore how teams are using it to drive operational efficiency across different deployment scenarios. What You Will Learn In this eBook, you will explore:...
Get your AI maturity score Take the assessment to learn how to accelerate your product and software development lifecycle with AI-powered development from a personalized AI maturity roadmap.[dsm_icon_list _builder_version="4.27.6" _module_preset="default"...
Register NowYou’ll be taken to a secure registration page to complete your sign-up.By submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.Modern product development teams are increasingly distributed across locations, suppliers, and...
Automotive manufacturers are arguably navigating the most significant transformation to the industry since the invention of the assembly line. Modern vehicles have evolved far beyond basic transport, as they are now sophisticated software-defined systems. These...