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.
The rise of Artificial Intelligence has led many businesses to reevaluate their operations. Can AI create better workflows or more efficient results? Dive into this eBook to explore the questions business leaders are asking about AI adoption. [et_bloom_inline...
Innovation is essential for staying ahead of competition in all industries, but especially in healthcare. Staying up to date with new technologies and compliance needs can improve outcomes for patients. The best way to ensure compliance is by utilizing the proper...
Businesses are becoming more reliant on technology than ever before, meaning that disruptions such as system failures, data breaches, or natural disasters are more impactful to operations. Additionally, these can lead to a loss of revenue and customer trust. Disaster...
Switching to new software tools can often seem like an exciting opportunity to streamline processes, increase efficiency, and modernize operations. Some executives seem to think that simply buying a new software tool will solve many problems at once. However, with...
