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...
In the aerospace industry, safety is non-negotiable. From passenger aircraft to defense systems, every airborne software component must meet rigorous standards. DO-178C serves as the benchmark for ensuring that aviation software is developed with the highest degree of...
In the aviation, space, and defense (AS&D) industries, a single component failure can lead to catastrophic consequences. To mitigate these risks and ensure consistent quality, the International Aerospace Quality Group (IAQG) developed the AS9100 Quality...
Delivering innovative products while ensuring quality and compliance can be tricky. Engineering teams in regulated industries must often navigate complexities such as Quality Management Systems (QMS) full of SOPs, work instructions, forms, and compliance...