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.
Are you interested in different types of SBOMs, but not sure which is right for you? Dive into this eBook to explore six different kinds of SBOMs and when to use them. What You Will Learn In this eBook, you will explore: Six kinds of SBOMs Which SBOM is best for you...
Medical device manufacturers know how rapidly technologies can change in the field. Ensuring you provide hospitals with innovative tools that meet regulatory requirements is vital. When a leading medical device manufacturer needed help upgrading software and hardware...
Accelerating product development, improving product quality, and enhancing collaboration are all main priorities for designers and manufacturers. Achieving these goals requires the proper digital solutions for managing product data and processes. Product Lifecycle...
Is your engineering team truly optimizing the cloud—or just getting by?The cloud holds enormous potential for accelerating innovation, streamlining workflows, and reducing time to market. But many engineering teams struggle to navigate the complexity of cloud...