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

Thought and Commentary for the Medical Device Industry

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Software Development Controls - Setup

October 17, 2019 | Posted by Satyajit Ketkar
Acceptable software development follows a series of repeatable steps that ensure that all requirements are met. There is no single “correct” software development process, but any good process must...

Software Development Controls - Developing Medical Device Software

October 14, 2019 | Posted by Satyajit Ketkar
Over the past two decades, perhaps the most significant change to the medical device industry has been the incorporation of software into a burgeoning number of medical devices. While this...

Design Controls (Part 6): Design Changes

September 19, 2019 | Posted by Ben Trombold
In a design-controlled project, no changes can be made to an approved design without the change being taken through the entire design process. Be aware of the following two factors when...

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:

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