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...
Register NowYou’ll be taken to a secure registration page to complete your sign-up.By submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.AI shouldn’t be a moonshot—it should be an operating model. In this practical session, SPK experts...
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...
Faster release cycles, stricter compliance standards, AI-driven development, and growing DevOps maturity expectations are putting enterprise software teams under more pressure than ever. Due to these factors, test management inside Jira must be scalable, secure, and...