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.
Ensuring your developers have the proper tools and processes to eliminate slowdowns and frustrations can be the difference between a great and a poor developer experience. Discover the importance of developer experience (DX) and how to improve it in this eBook.What...
The use of Large language models (LLMs) to generate production-ready code for product engineering teams is gaining popularity. With LLM usage gaining traction, quality assurance engineers and software development managers must ensure that these LLMs meet high...
Software comprises an entire ecosystem of open-source libraries, third-party components, containers, APIs, build pipelines, cloud services, and developer tools. This can be referred to as your software supply chain. High-profile cyberattacks often target dependencies...
Choosing the right platform to manage ideation, roadmapping, and alignment with engineering matters. While there are many, two heavy-hitters in this space are Jira Product Discovery (JPD) from Atlassian and Aha! from the company of the same name. This blog breaks...