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.
CAD engineers working across multiple systems can lead to collaboration issues and data sprawl. Discover how consolidating on one platform, such as PTC Creo, prevents unnecessary converting and importing. What You Will Learn In this eBook you will learn: The benefits...
Modern software development has reached a breaking point. Organizations are delivering code faster than ever, while attack surfaces expand across cloud-native architectures, microservices, open source dependencies, and AI-driven applications. Traditional application...
Hello everyone, and welcome back to today’s SPK and Associates blog: Why Integration Matters for Modern Engineering and Product Teams. My name is Michael Roberts. I’m the Vice President of Sales and Marketing here at SPK and Associates, where we work with...
As vehicle programs become more software-intensive, product variants multiply, compliance expectations rise, OEM timelines are not getting any easier. This puts automotive suppliers under immense pressure. Meanwhile, engineering teams are often still working across...