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.
Achieving compliance with ISO 9001 requires making quality and version control a priority. This eBook explores our experts’ ten best practices for ensuring ISO 9001 compliance.What You Will Learn Discover tips for achieving ISO 9001 certification such as: Establish a...
Product designs, documentation, and processes aren’t just valuable intellectual property, they’re your license to operate. In the highly regulated medical device industry, manufacturers must carefully consider these factors. If you’re using a Product Lifecycle...
Modern software development relies on version control systems to help teams manage changes, collaborate, and deliver high-quality code. Two popular Git workflows, Gitflow and Trunk-Based Development, offer different approaches to managing branches and releases....
Achieving compliance with ISO 9001 requires making quality and version control a priority. This eBook explores our experts’ ten best practices for ensuring ISO 9001 compliance.What You Will Learn Discover tips for achieving ISO 9001 certification such as: Establish a...