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.
Vehicles are only becoming more software-defined. As innovations break into the industry, automotive engineers and Tier 1 suppliers must keep up. Explore how they do so in this eBook.What You Will Learn Discover how: Software has become the differentiator in...
Vehicles are only becoming more software-defined. As innovations break into the industry, automotive engineers and Tier 1 suppliers must keep up. Explore how they do so in this eBook.What You Will Learn Discover how: Software has become the differentiator in...
Introduction Michael Roberts: Hello, 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 & Associates, and today we have a special guest. I'm joined by SPK's CEO and...
Key Takeaways Slow engineering onboarding delays productivity: Waiting for workstations, CAD software, VPN access, and engineering data can keep new hires and contractors from contributing for days or weeks. Cloud CAD removes hardware and setup bottlenecks:...