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.
Product teams all have the same goal: produce high-quality products and reduce time to market. Achieving these goals simultaneously can be difficult, but your team doesn’t have to sacrifice one for the other. Learn how in this eBook.What You Will Learn In this eBook,...
Key Takeaways Integrate your toolchain to eliminate manual handoffs, re-entry errors, and slow feedback loops between PLM, ALM, DevOps, and ITSM systems. Build end-to-end traceability with a connected digital thread so engineers can run impact analysis in minutes and...
Introduction Hello, everybody, and welcome back to another SPK & Associates Vlog. My name is Michael Roberts. I'm the Vice President of Sales and Marketing here at SPK. So today, we're going to talk about something that shows up on every engineering and IT budget...
Key Takeaways CSPM finds and fixes cloud risk before attackers do. Cloud security posture management continuously scans cloud environments for misconfigurations, excessive permissions, and compliance drift, then drives remediation. AI tools expand your cloud attack...