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.
Product teams all have the same goal: produce high-quality products and reduce time to market. Achieving these goals simultaneously can be difficult, but your team doesn’t have to sacrifice one for the other. Learn how in this eBook.What You Will Learn In this eBook,...
Key Takeaways: Disconnected PLM, ALM, DevOps, and quality systems impose a “hidden engineering tax,” turning engineers into human middleware who search for information, reconcile conflicting records, duplicate work, and chase changes by hand. The blog quantifies it...
Key Takeaways Successful Creo implementation starts with a clear plan. Involving engineering, IT, and management early helps align technical requirements with business goals and reduces deployment challenges. Hardware readiness and standardized workflows are...
Key Takeaways End-to-end traceability is essential for regulatory compliance. Connecting requirements, risks, tests, changes, and approvals helps organizations maintain accurate compliance records throughout product development. Connected traceability improves audit...