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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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Design Controls (Part 4): Design Outputs & Review

September 5, 2019 | Posted by Ben Trombold
Design outputs are the result of each design phase and of the entire design effort. A completed and finished design will culminate in the device itself, its labeling and packaging, and the device...

Design Controls (Part 3): Understanding Design Inputs

August 29, 2019 | Posted by Ben Trombold
Design inputs usually fall into three categories:

Design Controls (Part 2): A Closer Look at Planning & Design Inputs

August 22, 2019 | Posted by Ben Trombold
Our second blog post in this series surrounding Design Controls will focus on the initial steps in the process, Planning and Design Inputs.

Introduction to Design Controls

August 15, 2019 | Posted by Ben Trombold
While the word “design” often suggests a creative, trial-and-error process, design, as it applies to medical devices, must be a well-controlled, thoroughly documented process. Design controls are...

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...

Static Analysis (Part 4): Configuring Parasoft for Secure Development

July 29, 2019 | Posted by Satyajit Ketkar
Welcome back to our final installment of the series on Static & Dynamic Analysis, including Unit Testing. This last blog post will focus on the basics of the Parasoft testing tool, as well as provide...
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