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.
Solidworks and Creo are both popular 3D CAD solutions, and for good reason. They both offer a wide range of capabilities, but which system works best for your team?What You Will Learn In this comparison of Solidworks and Creo, you will discover the differences between...
As more organizations standardize on Atlassian Cloud for Jira and Confluence, there’s a growing assumption that “cloud” automatically means “protected.” After all, Atlassian is responsible for uptime, infrastructure, and platform reliability… right? Yes… but only...
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...
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,...