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...
Modern software teams are expected to ship faster, build more securely, and maintain reliability at scale, often while juggling a sprawling toolchain. The reality is sobering. 69% of developers spend at least a quarter of their time maintaining and integrating tools,...
What is The Value of DevSecOps? Hello and welcome to today’s SPK and Associates vlog. My name is Michael Roberts, Vice President of Sales and Marketing here at SPK. DevSecOps has become a strategic priority for engineering organizations. But with so many platforms 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...