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.
Although AI tools are easily accessible, helpful aids, many organizations are slow to adopt them. In this eBook, Atlassian explores how AI can redefine knowledge sharing and how your teams can adopt it with confidence.What You Will Learn In this guide, you will...
While nearly every engineering organization is using artificial intelligence in some form, there are some hoops teams must jump through before integrating AI. Inside most large enterprises, the authority sits with an AI governance board. These boards exist to...
Introduction to Appsvio Hello everyone, and welcome to this SPK and Associates video entitled Modern Test Management for Regulated Industry Software Teams. I’m Michael Roberts, Vice President of Sales and Marketing for SPK and Associates. Today we’re going to talk...
CI/CD is an important aspect of software engineering that directly impacts engineering velocity, release confidence, and total cost of ownership. So, with the upcoming 2026 pricing changes to GitHub Actions, many teams are asking a fair question: Are we paying the...