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.
Developing products can lead to environmental costs based on the materials used and how they are handled pre- and post-production. Let’s explore how Creo helps drive sustainable product development practices.What You Will Learn In this eBook, you will discover how to:...
Protecting documentation inside project tools like Jira Cloud can be a challenge in regulated environments. Whether you're managing technical files, contracts, or quality compliance records, attachments are often scattered and exposed to unnecessary users....
Modern software is assembled from a complex web of components, contributors, and tools, both internal and external. While this modularity accelerates development, it also expands the attack surface. For executives, a single breach in the software supply chain can...
Tariffs have long been a tool of economic strategy, but recent escalations are impacting U.S. manufacturers, especially in the medical device industry. From 10% baseline tariffs to 245% duties on Chinese imports, companies now face inflated costs and disrupted global...