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.
Developing high-quality products quickly can be a challenge without the proper tools, processes, and partners to help. Dive into this eBook to discover how partnering with SPK can help you achieve product development success.What You Will Learn In this eBook, we will...
Licensing costs can be expensive, especially when you have large teams utilizing multiple tools. In the case of one of our clients, a medical equipment supplier, they were spending thousands of dollars on dozens of tools. Luckily, with the help of SPK as their...
As the world of engineering continues to evolve, so does the need for more sophisticated tools to manage complex calculations and data. The end-of-sale of Mathcad 15 and Mathcad Prime 1.0-6.0 marks a significant shift, as PTC moves forward with its latest offering,...
Getting products designed and manufactured quickly is necessary to stay afloat in a competitive market. When working with software-driven products, this timeline can be stricter. Whether you're launching a new application or updating features for a legacy product,...