Defining Requirements Here’s where the Systems Engineer really goes into top gear. The task is to integrate all inputs from preceding phases and discussions to define requirements and elaborate them...
Welcome back to our blog series on Controlled Software Development for medical devices! In our last post, we looked at the significant Input phases of software development; this post, we’ll start to...
Welcome back to our blog series on Controlled Software Development for medical devices! In this post, we’ll look at the significant Input phases of software development: User Needs, Risk & Security...
Acceptable software development follows a series of repeatable steps that ensure that all requirements are met. There is no single “correct” software development process, but any good process must...
Over the past two decades, perhaps the most significant change to the medical device industry has been the incorporation of software into a burgeoning number of medical devices. While this...
On October 18th, 2018, the FDA released a draft guidance named “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”. Even though most of the activities and...
