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Improving Lives for a Better World, One Device at a Time

Thought and Commentary for the Medical Device Industry

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Introduction to Static Analysis

July 8, 2019 | Posted by Satyajit Ketkar
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...

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...

Root of Trust #10 - Why BLE?

June 27, 2019 | Posted by Chris Gates
There are a large number of wireless solutions available, each with their own positive and negative attributes. Identifying the optimum wireless choice to employ for a given use case is critical...

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...

Root of Trust #9 - An Uncomfortable Question

June 20, 2019 | Posted by Chris Gates
The other day I was participating in an InfoSec working group when one of the participants asked a pertinent and uncomfortable question:

Standards-centric vs. Product-centric in Lean QMS

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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