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.
Knowing how to integrate AI into your workflows can be the difference between risky, inefficient implementation and successful performance that brings lower costs and a faster time-to-market. This eBook explores how your teams can effectively utilize AI.What You Will...
Complex product development involves multi-disciplinary teams, with systems engineers or requirements analysts producing the requirements, and other disciplines creating designs and tests based on those requirements. Serious problems can arise if all teams do not have...
Engineering teams are becoming more distributed due to designers, analysts, contractors, suppliers, and product teams working across locations. Despite their distance, these teams must access the same data. This includes CAD files, simulation results, product...
Hello everybody, and welcome back to another SPK and Associates vlog. My name is Michael Roberts. I'm the Vice President of Sales and Marketing here at SPK. Today we're talking about how industrial manufacturers are accelerating their time to market up to 15% by using...