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.
HR teams can struggle to manage all of their demands without the right tools. Discover how HR teams can utilize Jira Service Management (JSM) to achieve success. What You Will Learn In this eBook, you will discover: JSM’s high velocity approach to HR management How...
Introduction to the Topic: Moving Off Windchill RV&S Hi everybody, and welcome to this SPK and Associates vlog entitled The Top Five Pitfalls to Avoid When Moving Off Windchill RV&S. My name is Michael Roberts. I'm the Vice President of Sales and Marketing...
Introduction and CleverDev Overview Release Readiness and Engineering Intelligence Welcome back to another SPK and Associates vlog. My name is Michael Roberts, Vice President of Sales and Marketing here at SPK and Associates. Today, we're talking about challenges that...
For many engineering teams, file-based Product Data Management (PDM) tools are the first step toward controlling design data chaos. Solutions like SolidWorks PDM bring order to CAD files, versions, and check-in and check-out processes. For a time, this is enough....