In our previous posts, we looked at the importance of integrating human factors engineering (HFE) processes throughout product development. FDA approval for your device may require a Human Factors...
Welcome back to our series on static & dynamic analysis and unit testing. In this post, we discuss dynamic analysis, which is when you actually execute the program on a real or virtual machine to...
As we resume our discussion of Human Factors Engineering (HFE) for medical devices, it's worth repeating that HFE should be thoroughly incorporated into the development process. HFE is about working...
Welcome back to our series on Static & Dynamic Analysis, including Unit Testing. Our previous post provided a brief introduction to static analysis, what it is, and how it has developed. Today we’re...
Regardless of industry, any company writing code understands the need for standardization and proof-checking, and the medical device sector is no different. What is different is the emphasis on...
The principal objective of a QMS for a medical device company is patient safety. Patient safety is well understood and communicated throughout the medical device industry, leading to an almost...
