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.
IBM DOORS has remained a consistent tool for managing software requirements. However, it has not kept up with the modern landscape. Explore options such as DOORS NG and other next-generation ALM tools in this eBook.What You Will Learn In this eBook, you will discover:...
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...
Fernando Mino is a Systems Support Engineer who joined SPK and Associates in 2022. Before joining SPK, Fernando had worked in various fields, including teaching English in Ecuador and serving as an airport engineer in various parts of Europe. In his current role, he...
Biopharma and medtech leaders are under constant pressure to accelerate clinical development and satisfy increasingly demanding regulators. Digital transformation is the way to do this. This doesn’t just mean adopting new tools, but rather rethinking how science,...