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.
Simulation-driven design (SDD) is an approach to product development that uses simulation tools throughout the design lifecycle. Dive into this eBook to discover how Ansys and PTC are utilizing SDD to empower design engineers and drive innovation and efficiency.What...
Simulation-driven design (SDD) is an approach to product development that uses simulation tools throughout the design lifecycle. Dive into this eBook to discover how Ansys and PTC are utilizing SDD to empower design engineers and drive innovation and efficiency.What...
The commercial lending company, mysherpas, offers an intuitive platform for lenders and borrowers. This platform, while eliminating unnecessary paperwork, can be difficult to maintain. Explore how SPK’s development team aided mysherpas in the following case study....
Designing and manufacturing aerospace products demands precision, innovation, and an unwavering commitment to safety. Engineers must balance complex assemblies and stringent regulatory standards while using lightweight materials. PTC Creo provides a comprehensive...