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.
Modern developers are either upgrading their technology or falling behind. Discover how new CAD technologies and other product design tools are altering the engineering space.What You Will Learn Discover how technologies like Creo and Creo+ from PTC are helping...
Modern developers are either upgrading their technology or falling behind. Discover how new CAD technologies and other product design tools are altering the engineering space.What You Will Learn Discover how technologies like Creo and Creo+ from PTC are helping...
Open source software is everywhere, and for good reason. It drives innovation, giving teams access to powerful tools and frameworks without licensing fees. While the benefits are clear, hidden open-source components in your product can introduce risks. These include...
Scotts Valley, CA-based consulting firm, SPK and Associates, is on Channel Partners 2025 MSP 501 for the 7th year in a row. The annual Channel Partners MSP 501 list, a technology industry benchmark, ranks companies based on a wide range of metrics. These include...