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.
Achieving fast, efficient support is vital for customer satisfaction. Atlassian’s new app helps connect customer support with development, product, and operations on one platform. What You Will Learn In the following eBook, you will explore: Key features of the app,...
Introduction Hello, and welcome to this SPK and Associates vlog. My name is Michael Roberts. I'm the Vice President of Sales and Marketing with SPK. Now, everybody knows that artificial intelligence is transforming the way that organizations develop products, write...
Today, product development almost always involves a data center. And the data center is more than just a collection of servers and racks. For a global medical technology leader, it is the heartbeat of the engineering organization. It houses the mechatronics...
The aerospace industry is facing a slowdown in development timelines and higher quality costs. A digital thread resolves these issues by creating a unified, intelligent product lifecycle that connects design, manufacturing, and service.What You Will Learn In this...