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Thought and Commentary for the Medical Device Industry

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Design Controls (Part 2): A Closer Look at Planning & Design Inputs

August 22, 2019 | Posted by Ben Trombold
Our second blog post in this series surrounding Design Controls will focus on the initial steps in the process, Planning and Design Inputs.

Introduction to Design Controls

August 15, 2019 | Posted by Ben Trombold
While the word “design” often suggests a creative, trial-and-error process, design, as it applies to medical devices, must be a well-controlled, thoroughly documented process. Design controls are...

Static Analysis (Part 3): An Introduction to Dynamic Analysis

July 22, 2019 | Posted by Satyajit Ketkar
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...

Quality Systems (Part 6): Four Goals of a Valuable QMS

July 1, 2019 | Posted by Randy Armstrong
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...

Quality Systems (Part 5): Simple is Hard, but Simple is Worth it

June 24, 2019 | Posted by Randy Armstrong
In the second blog post in this series, we explained that a lean QMS results in less complicated devices, which in turn decreases development time, cost, and, in many cases, patient risk. Less is...

Quality Systems (Part 4): Standards-centric vs. Product-centric

June 17, 2019 | Posted by Randy Armstrong
In the 4th part of this series, we are going to talk about the differences between a QMS that is standards-centric and one that is product-centric.

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