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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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Human Factors Engineering (Part 3): Validation Testing

July 25, 2019 | Posted by Mark Kraft
In our previous posts, we looked at the importance of integrating human factors engineering (HFE) processes throughout product development. FDA approval for your device may require a Human Factors...

Human Factors Engineering (Part 2): Reorder for Safety

July 18, 2019 | Posted by Mark Kraft
As we resume our discussion of Human Factors Engineering (HFE) for medical devices, it's worth repeating that HFE should be thoroughly incorporated into the development process. HFE is about working...

Static Analysis (Part 2): Regulations, Standards, & Best Practices

July 15, 2019 | Posted by Satyajit Ketkar
Welcome back to our series on Static & Dynamic Analysis, including Unit Testing. Our previous post provided a brief introduction to static analysis, what it is, and how it has developed. Today we’re...

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...

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 to a...

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:
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