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 agile methodology is an iterative process that delivers high-quality products quickly. In modern development, this process drives continuous improvement. In this eBook, you will explore common issues to avoid.What You Will Learn Explore these top nine blunders and...
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...
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....
Implementing a Quality Management System (QMS) that ensures compliance with ISO 9001 is a strategic decision for organizations. Implementing this system enhances customer satisfaction, improves efficiency, and drives continuous improvement. However, achieving ISO 9001...