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.
Atlassian’s System of Work is a powerful combination of tools that help cross-functional teams collaborate. At the heart is Jira. Dive into this eBook to learn more about Jira’s role. What You Will Learn In this eBook, you will explore: Jira’s features that simplify...
With constant pressure to deliver high-quality products, Model-Based Definition (MBD) has emerged as a game-changer. MBD is particularly useful for companies aiming to achieve precision manufacturing and meet compliance regulations. By using MBD in CAD, manufacturers...
The EU Medical Device Regulation (EU MDR) transition is a significant regulatory shift that medical device companies must take seriously. Replacing the previous Medical Device Directive (MDD), the EU MDR (Regulation (EU) 2017/745) introduces more stringent...
Regulated industries face immense complexity in designing, producing, and maintaining high-quality products. Balancing this while ensuring compliance, managing data, and accelerating innovation is not possible without the proper tools. That’s why Product Lifecycle...