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.
Viewing AI as a partner rather than a tool can save organizations time and money. Discover how AI can improve productivity in this downloadable eBook.What You Will Learn In this eBook, you will discover how: Atlassian’s AI assistant, Rovo, empowers organizations AI...
What does the average planning meeting look like for a product development company? Product managers are likely eager to introduce innovations and customer-driven features. Engineers are waving red flags about technical debt, scalability issues, and quality risks....
Viewing AI as a partner rather than a tool can save organizations time and money. Discover how AI can improve productivity in this downloadable eBook.What You Will Learn In this eBook, you will discover how: Atlassian’s AI assistant, Rovo, empowers organizations AI...
In this episode of All About Accelerating Products, we sit down with Charles Hardin, Senior Director of Software Engineering at RedoxBlox, a company pioneering renewable energy management solutions for industrial applications. With over 20 years of experience scaling...