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...
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...
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.Manufacturers are under increasing pressure to improve productivity while facing labor shortages, rising costs, and growing product...
Developer experience (DX) is more than just a buzzword. It underpins how fast you can build, how well you deliver, and how happy your engineering team remains. When DX is ignored, you see frustrated developers, siloes, bloated toolchains, and slower innovation. ...