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.
Managing your organization’s knowledge base may be challenging, especially if information is scattered across multiple systems. Discover how Atlassian’s AI Rovo agents help manage this.What You Will Learn In this eBook you will discover: Why knowledge management...
Requirements Management in Software Development Carlos:I’m Carlos Almeida, Engineering VP at SPK and Associates. I have years and years of experience with very large projects in software development and infrastructure, DevOps, regulated and unregulated industries. I...
Successful medical equipment installation in hospitals requires continuous stakeholder engagement, infrastructure readiness, testing and training, and continued maintenance. When done properly, staff can quickly and easily use the devices, directly elevating patient...
For years, IBM Rational DOORS has been a cornerstone for requirements management in highly regulated industries. Unfortunately, as development practices evolve, DOORS has not evolved with them. One of the biggest challenges with this is that there’s no direct upgrade...