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.
Utilizing AI tools can help your organization achieve more. Discover the benefits of Atlassian Intelligence and Rovo in this downloadable eBook.What You Will Learn Explore the benefits of Atlassian Intelligence, such as: Accelerating productivity Unlocking...
Choosing a 3D CAD engineering software can be difficult when there are so many different options on the market. This eBook will explore the considerations your company should take before selecting one. What You Will Learn In this eBook, you will discover which...
From my decades of experience in the IT and Engineering space, I’ve seen firsthand how even the most capable engineering teams can falter under the weight of compliance requirements. In highly regulated industries, the need to innovate quickly often clashes with the...
Developing potentially life-saving products requires unparalleled performance, security, and compliance. However, as medical technology continues to evolve, so does the complexity of managing the systems that power it. Hospitals and healthcare providers are facing...