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Blog

Thought and Commentary for the Medical Device Industry

Systems Engineering Development Lifecycle - Confirm, Build, Deploy

November 14, 2019 | Posted by Satyajit Ketkar
Transfer to Manufacturing Just prior to Transfer to Manufacturing, the System Engineer assists the Manufacturing Lead Engineer or Manager with identifying the product variables (such as pass/fail...

Systems Engineering Development Lifecycle - Get Set, Go!

November 11, 2019 | Posted by Satyajit Ketkar
Implementation The Implementation phase is where most of what we’re ordinarily tempted to think of as the “actual work” of the project takes place. However, as essential as the work done during...

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...