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.
CI/CD makes modern software development quicker and easier. Dive into this in-depth guide to explore what CI/CD can do for your organization.What You Will Learn Discover topics such as: CI/CD fundamentals The benefits of CI/CD Differences between CI/CD and...
Product Lifecycle Management (PLM) solutions are evolving with advances in cloud computing, AI, automation, and sustainability initiatives. For engineering leaders, staying ahead of these changes is critical to driving innovation, maintaining compliance, and improving...
Hospitals depend on medical devices every day to deliver safe, accurate, and timely care. From imaging systems and surgical tools to specialized recording platforms, the reliability of this equipment directly impacts patient outcomes and operational efficiency. When...
Introduction: How To Configure CI/CD Pipelines in GitLab Hello and welcome to how to configure your first GitLab CI/CD pipeline. My name is Michael Roberts, I'm the vice president of sales and marketing here at SPK and Associates and I'm here today with. Darla Kost....