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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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Root of Trust #8 - It's All About the Vulnerabilities!

June 13, 2019 | Posted by Chris Gates
What should we in the world of Embedded InfoSec be focused on?

Balancing Empowerment Against Control in a Lean QMS

June 10, 2019 | Posted by Randy Armstrong
In the 3rd part of this series, we address how to balance empowering a design team to create a medical device that provides safe and effective therapy or diagnostic, while still ensuring adequate...

Root of Trust #7 - Lightening the Load for End Users

June 6, 2019 | Posted by Chris Gates
I recently attended a presentation on “Risk-based Cybersecurity”. I’ll admit I was skeptical before I even sat down - the title sounded like it was going to be a way to paper over ‘doing nothing’...

Developing a Lean QMS

June 3, 2019 | Posted by Randy Armstrong
Implementing a lean QMS is not about cutting corners. It is about corporate focus, which in our case means being risk-driven to create safe and effective devices as quickly and cost-effectively as...

Root of Trust #6 - Collapsing SEP: the Hitchhiker's Guide to Securing the Galaxy

May 30, 2019 | Posted by Chris Gates
I just returned from a large trade show (it doesn’t matter which industry this was, this applies to almost all of them), and was struck by what Douglas Adams, author of The Hitchhiker’s Guide to...

Introduction to Lean QMS

May 27, 2019 | Posted by Randy Armstrong
In the medical device industry, every company knows the necessity of a Quality Management System (QMS) for managing internal processes and tracking work to regulatory requirements. Many companies...
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