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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 4): 7 Additional Resources

August 1, 2019 | Posted by Mark Kraft
When developing a new device using Human Factors Engineering (HFE), researching known use- and design-related issues and hazards that have already been identified for devices similar to yours – or...

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...

An Introduction to Human Factors Engineering for Medical Devices

July 11, 2019 | Posted by Mark Kraft
When it comes to medical device safety, having fully-integrated human factors engineering (HFE) processes in place throughout development is absolutely critical.

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...

Human Factors Engineering: 7 Additional Resources

July 25, 2017 | Posted by Mark Kraft
When developing a new device using Human Factors Engineering (HFE), researching known use- and design-related issues and hazards that have already been identified for similar devices can give you...
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