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

Thought and Commentary for the Medical Device Industry

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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.

Quality Systems (Part 3): Balancing Empowerment vs. Control

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...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part I

March 5, 2019 | Posted by Ben Trombold
FDA 2016 Guidance on Cybersecurity within Medical Devices

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