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...
In modern manufacturing, the systems we use to manage production often feel like they were built for a different era. When engineering leaders evaluate Manufacturing Execution Systems (MES), they frequently encounter a choice between the way it’s always been done and...
The rapid integration of Artificial Intelligence into the modern engineering workplace has promised a new era of efficiency. From Atlassian Rovo to GitLab Duo, AI agents are now capable of summarizing complex documentation, generating code, and managing Jira workflows...
Traditional engineers often view data as a byproduct of the design process. They store data in static PDF reports or miscellaneous CAD files. However, as we enter the era of digital engineering, that perspective is shifting. Today, product data is no longer just a...