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.
Developing high-quality products quickly can be a challenge without the proper tools, processes, and partners to help. Dive into this eBook to discover how partnering with SPK can help you achieve product development success.What You Will Learn In this eBook, we will...
Compliance with regulatory standards is the number one priority for every medical manufacturer. Ensuring pipelines are secure and compliant doesn’t just ensure safety, but it results in better quality products. When a startup medical manufacturing company contacted...
Balancing speed and compliance in medical device engineering can be challenging. Engineers face tight deadlines and detailed requirements to bring life-saving products to market. Your CAD workflows should aid in the path to compliance and accelerate FDA approval. As...
GitLab has officially released version 17.8. This update offers significant enhancements across security, DevOps workflows, and machine learning capabilities. With over 60 improvements, this release further solidifies GitLab's role as the most comprehensive AI-powered...