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.
Creating products isn’t always challenging, as the right tools and systems can work together to ensure smooth delivery. However, delivering products that solve real customer problems can be a challenge. Dive into this eBook to explore how Atlassian’s Jira and...
Creating products isn’t always challenging, as the right tools and systems can work together to ensure smooth delivery. However, delivering products that solve real customer problems can be a challenge. Dive into this eBook to explore how Atlassian’s Jira and...
Whether building software or supporting employees with the right technology, efficiency and collaboration define success. Enterprises rely on seamless communication between teams to deliver reliable software and maintain top-tier service performance. However, DevOps...
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.AI is rapidly changing how software is built but simply adding AI coding assistants on top of an already fragmented toolchain often...