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.
While using a singular ITSM tool may be simpler, many organizations utilize multiple for their unique features. This often results in Jira Service Management, ServiceNow, and Freshservice working in tandem. Integrating these tools can be harder than it appears, but...
In the high-stakes world of mechatronics and regulated product development, the tools that drive your CI/CD pipeline are more than just infrastructure. They are the backbone of your delivery reality. For years, Atlassian Bamboo served as a reliable workhorse for...
For decades, buying high-powered CAD workstations was simply the cost of doing engineering. When design tools needed more computing power, IT bought more powerful machines. When engineers complained about slow performance, companies refreshed hardware. If a new hire...
Engineering leadership often faces a difficult choice between adopting cutting-edge innovation and maintaining strict data sovereignty. This balance is particularly delicate in regulated environments like medical device manufacturing, automotive engineering, and...