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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 - Requirements & Design

November 7, 2019 | Posted by Satyajit Ketkar
Defining Requirements Here’s where the Systems Engineer really goes into top gear. The task is to integrate all inputs from preceding phases and discussions to define requirements and elaborate...

Systems Engineering Development Lifecycle - First Things First

November 4, 2019 | Posted by Satyajit Ketkar
So, your company has decided to move ahead with the product! That means it’s time to map out the project schedule and resources and define how, exactly, this product will move from IP to reality.

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 &...
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