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.
Solidworks and Creo are both popular 3D CAD solutions, and for good reason. They both offer a wide range of capabilities, but which system works best for your team?What You Will Learn In this comparison of Solidworks and Creo, you will discover the differences between...
Introduction: Manufacturing with Tulip Hello and welcome. My name is Michael Roberts, Vice President of Sales and Marketing with SPK and Associates. Today we're here to talk about a topic that is really important for manufacturers. Manufacturers are constantly under...
Software development teams are under constant pressure to deliver new features faster. Balancing this with maintaining strong security and compliance standards isn’t always easy. Artificial intelligence is rapidly changing that. AI-powered tools are helping...
Think about the day-to-day operations of your organization. How many tools do you utilize? Sales teams often work within Customer Relationship Management (CRM) platforms such as Microsoft Dynamics 365. Meanwhile, development teams operate in Application Lifecycle...