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.
CAD engineers working across multiple systems can lead to collaboration issues and data sprawl. Discover how consolidating on one platform, such as PTC Creo, prevents unnecessary converting and importing. What You Will Learn In this eBook you will learn: The benefits...
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.Many organizations struggle to achieve true traceability and compliance because critical data is scattered across disconnected tools used...
CAD engineers working across multiple systems can lead to collaboration issues and data sprawl. Discover how consolidating on one platform, such as PTC Creo, prevents unnecessary converting and importing. What You Will Learn In this eBook you will learn: The benefits...
Advanced driver assistance systems, connected vehicle services, and electrification platforms. What do all of these features have in common? The answer: software. As these features increasingly make their way into mainstream automotive development, vehicles are...