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.
As businesses modernize, cloud solutions and AI seem to be the default. Dive into this eBook to explore why this is, as well as some modernization strategies.What You Will Learn In this eBook, you will learn how: AI is driving modernization Cloud is delivering results...
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...
In the tech space and beyond, modern buzz has all pointed to AI. While I love exploring new ideas, I am also quite a pragmatist. This past year, I’ve navigated through endless white papers, blogs, books, videos, social posts, and articles about AI. These detail how it...