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.
Utilizing containers can have many benefits for organizations in the IT realm. However, some teams experience pushback to adopting this technology due to security concerns. Let’s explore ways to ensure secure container deployments for your teams. What You Will Learn...
Delaying a product launch can have significant financial repercussions that extend far beyond the immediate costs. It is important to understand how these delays can impact an organization. Having this knowledge can transform an organization’s strategic plans and...
Driving AI adoption among teams is not always an easy task, especially when distrust or collaboration issues are present. Dive into this eBook to discover how to streamline AI adoption. What You Will Learn In this eBook from Atlassian, you will explore four main ways...
You will be taken to another page to registerBy submitting this form, I acknowledge receipt of SPK and Associates' Privacy Policy.As engineering teams face increasing demands for flexibility, scalability, and collaboration, traditional on-premise CAD solutions often...