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.
While using a singular ITSM tool may be simpler, many organizations utilize multiple for their unique features. This often results in Jira Service Management, ServiceNow, and Freshservice working in tandem. Integrating these tools can be harder than it appears, but...
When developing complex products, visibility is the difference between a successful launch and a costly recall. Yet, despite having more tools than ever, most engineering leaders feel like they are flying blind. Critical information is scattered across a fragmented...
PTC NEXT Spring 2026 showcased a clear vision for the future of engineering software: connected product data, AI-powered workflows, modern cloud platforms, and an increasingly integrated digital thread spanning CAD, PLM, ALM, manufacturing, and service operations....
Every managed service provider has to deal with some sort of custom integration. This could be a Python script running on a server, a Groovy snippet inside a Jira automation, or a Zapier workflow set up by an intern. These integrations share a common origin. A team...