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...
Engineering leadership often faces a difficult choice between adopting cutting-edge innovation and maintaining strict data sovereignty. This balance is particularly delicate in regulated environments like medical device manufacturing, automotive engineering, and...
SPK and Associates is proud to announce that we are recognized by Channel Partners as a top managed service provider of 2026. The MSP 501 is the technology industry’s prestigious ranking of the world’s top managed service providers. This marks SPK’s eighth consecutive...
AI coding tools are quickly becoming part of everyday software development. Tools like Cursor, GitHub Copilot, GitLab Duo, and other AI assistants are helping developers generate code, complete repetitive tasks, and review pull requests. Software organizations are no...