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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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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 to...

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 & Security...

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...

5 Additional Benefits Your UDI Could Be Providing

September 26, 2019 | Posted by Devin Carroll
You have been working hard to place Unique Device Identification (UDI) numbers on each of your devices. You now know more about bar codes, QR codes, scanner systems, and federal databases than you...

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 implementing...
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