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.
As 63% of companies plan to increase AI spending this year, there is a large focus on the ROI of AI tools. Ensuring you get the most out of your investment is vital to business success, especially in the service industry. This eBook explores how teams can integrate AI...
Introduction Hello, and welcome back to another SPK and Associates vlog. In this vlog, we're going to talk about how engineering organizations are evolving to support more complex multidisciplinary products. And with that, choosing the right platform that you're going...
Over the past six months, Google has expanded Gemini from a set of helpful AI features into a broader platform capability. It spans across content creation, reporting, search, collaboration, and administrative oversight. That shift means IT, security, compliance,...
As an automotive engineer, it is hard to ignore the rise of software-defined vehicles and electrification. When combined with strict compliance expectations and growing pressure to innovate faster, traditional engineering systems just aren’t cutting it. On-premise...