Imagine developing a medical device or drug that could be claimed to work without any evidence….

Often in medical device product development, functions exist in silos. Risk, requirements, and test management functions often exist separately, on their own - different systems, different teams, different objectives. Yet, the data related to these functions are both continuously changing and highly dependent on one another. Some type of process is needed to (1) manage the effect of changes across all three systems and (2) provide evidence of a process for notified bodies if and when needed.

Commonly issued after an FDA inspection, a Form 483 informs a company of observations requiring corrective actions. The Form 483 is often referred to as “Inspectional Observations” as it is a list of conditions or practices that indicate a potential violation of FDA requirements. The form is compiled in order of importance and is considered a snapshot of potential issues; it should not be considered all-encompassing.