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.
Software-defined and electric vehicles are only increasing as automotive technology advances. As these features grow, automakers must adapt. Manufacturing a car is not the same as it was years ago. This eBook explores how AI can be used in the automotive development...
Key Takeaways Governance must come before scale: AI agents can access data and take actions, meaning clear rules around what they can see and do must be established before widespread deployment. Follow the principle of least privilege: Agents should only receive the...
Key Takeaways A connected digital thread helps prevent schedule delays: Linking CAD, simulation, PLM, ALM, and DevOps gives aerospace teams better visibility into dependencies, changes, and risks across the lifecycle. Earlier validation reduces costly rework: Creo and...
Security and Innovation in Aerospace & Defense Hello, everybody, and welcome to this SPK and Associates vlog. My name is Michael Roberts, and I'm the Vice President of Sales and Marketing here at SPK. Today, we're going to talk about the tug-of-war between...