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.
Where To Start & Why It Matters What is the Atlassian Cloud Zero Trust Security model? Well, for decades, enterprise security controls were built to protect a large, single perimeter around a corporation. Often described as castle-and-moat security, This approach...
Knowing how to improve DevOps can be challenging. But, creating an integrated DevOps toolchain can set organizations apart from the rest. This is because having a well-defined business DevOps journey can reduce errors, improve collaboration and drastically increase...
Cybersecurity should be baked into the onset of IT and product development processes. Additionally, treating cybersecurity as an afterthought opens your organization up to vulnerabilities and risk. Therefore hardening your IT product cybersecurity with a tool like...
There’s been a lot of innovation, software and product releases in the past six months alone. So, we are rounding up the best tech review and engineering releases for the first half of 2022. The tech forecast for 2022 was heavily influenced by how the world adjusted...
