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

Thought and Commentary for the Medical Device Industry

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A Summary of Medical Device Standards - Part I - Know Your Bodies

March 7, 2019 | Posted by Tim Carroll
Federal standards governing the safety and efficacy of medical products have been overseen in the United States by the FDA since the original 1906 Food and Drugs Act. The approach to medical...

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

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

Quality Management for Software as a Medical Device

November 16, 2017 | Posted by Sean Carroll
Successful quality management for Software as a Medical Device (SaMD) will have 3 preeminent distinctives:

Root of Trust #10 - Why BLE?

November 14, 2017 | 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...

Agile Development for Medical Devices - Part II

October 20, 2017 | Posted by Jason Swoboda
Our last agile development post focused on the big picture: when, how, and why to depart from the classic waterfall development model in favor of lean and agile practices. But what does that look...

Root of Trust #9 - An Uncomfortable Question

October 18, 2017 | 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:

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