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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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Systems Engineering Development Lifecycle - the Role

October 31, 2019 | Posted by Satyajit Ketkar
For this series, the Velentium blog welcomes back Principal Systems Architect Satyajit “Sat” Ketkar. Sat’s career encompasses nearly twenty years of electrical, firmware, software, and systems...

Software Development Controls - Testing, Wrap-Up, & Handoff

October 28, 2019 | Posted by Satyajit Ketkar
Welcome to the final installment of our series on Controlled Software Development for medical devices. With the design, implementation, and early testing phases completed, it is time to move on to...

Software Development Controls - Outputs

October 24, 2019 | Posted by Satyajit Ketkar
Welcome back to our blog series on Controlled Software Development for medical devices! In our last post, we looked at the significant Input phases of software development; this post, we’ll start...

Software Development Controls - Inputs

October 21, 2019 | Posted by Satyajit Ketkar
Welcome back to our blog series on Controlled Software Development for medical devices! In this post, we’ll look at the significant Input phases of software development: User Needs, Risk &...

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...
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