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.
Are you ready to secure your mission, empower all teams, and serve every citizen? The future of government work is here, and it's called the Atlassian Government Cloud.What You Will Learn Legacy systems cannot compete with the capabilities of the cloud. In this eBook,...
Advanced driver assistance systems, connected vehicle services, and electrification platforms. What do all of these features have in common? The answer: software. As these features increasingly make their way into mainstream automotive development, vehicles are...
Introduction: Manufacturing with Tulip Hello and welcome. My name is Michael Roberts, Vice President of Sales and Marketing with SPK and Associates. Today we're here to talk about a topic that is really important for manufacturers. Manufacturers are constantly under...
Introduction to Multiplier Hi, and welcome to another SPK and Associates vlog. My name is Michael Roberts, a Vice President of Sales and Marketing here at SPK and Associates. In today’s vlog, we’re going to talk about how growing organizations wrestle with scaling...