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Thought and Commentary for the Medical Device Industry

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Design Controls (Part 5): Verification & Validation

September 12, 2019 | Posted by Ben Trombold
As with risk management, verification and validation are essential topics that must be investigated separately in order to make sure they are fully understood. Yet these are integral steps in the...

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...

Static Analysis (Part 3): An Introduction to Dynamic Analysis

July 22, 2019 | Posted by Satyajit Ketkar
Welcome back to our series on static & dynamic analysis and unit testing. In this post, we discuss dynamic analysis, which is when you actually execute the program on a real or virtual machine to...

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