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

How We Help

Our Values

Honorable

We do Right for Right's sake
We will make decisions that are based on right and wrong. That means that you'll always know the status of your project. That means that you'll be told when something is out of scope before we make any changes. That means that we will be punctual. That means that we will do everything in our power to treat you like we would like to be treated.

Results ++

We do the job and then some
It isn't enough to be average. It isn't enough to just "do the job". Our staff pride themselves in delighting clients with their work. We want to be that service experience where you walk away saying "WOW!". We aren't really interested in one project with you and your colleagues. We are interested in decades of relationship that is fueled by Results++

Humble Charisma

We strive to be the kind of people you want to be around
There are charismatic people in this world that tell you all about it. There are humble people in this world that never get noticed. We strive for a perfect balance. At the end of an engagement, we hope that you like our staff for who they are and not just what they have accomplished. We want to get to know you and hope you enjoy getting to know us. After all, it's people that make up businesses and working with others is what we like best!
Quality Driven

ISO 13485 Certified

Not only do we follow the standards, we helped write them! We adhere to them smartly – with compliant efficiency.
Certified to: ISO 13485 – Quality Management Systems
Compliant with: ISO 14971 - Risk Management, IEC 62304 - Software, IEC 60601 - Electrical, ISO 62366 - Useability, ISO 14708 - Active Implantables
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World Class Innovation in Medical Devices

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Expertise in What Matters to You

Velentium is a professional engineering firm, specializing in the design and development of secure implantable devices, medical apps, and medical device data systems.

Human Factors Engineering

Human Factors Engineering

Embedded Cybersecurity

Embedded Cybersecurity

Automated Test Systems

Automated Test Systems

Electrical Design

Electrical Design

Systems Engineering

Systems Engineering

Mechanical Design

Mechanical Design

Firmware

Firmware

Mobile Apps

Mobile Apps

Cloud-Based Applications

Cloud-Based Applications

Get Started Today!
Blog

Thought and Commentary for the Medical Device Industry

Agile Development for Medical Devices - Part II

April 18, 2019 | Posted by Jason Swoboda
Our last agile development post focused on the big picture: when, how, and why to depart from the classic waterfall development model in favor of lean and agile practices. But what does that look...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part VII - Cybersecurity Documentation Required for Submission

April 15, 2019 | Posted by Ben Trombold
Welcome to the final installment of our breakdown of the new FDA cybersecurity standards In this post, we’ll look at required documentation manufacturers need to include in their premarket...

Agile Development for Medical Devices - Part I

April 11, 2019 | Posted by Jason Swoboda

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part VI - Cybersecurity Labeling

April 8, 2019 | Posted by Ben Trombold
Labeling is any written text that identifies any part of a medical device. This includes a label directly on the device, user manuals, instructions for use (IFU), labels present on the outside of...

Quality Management for Software as a Medical Device

April 4, 2019 | Posted by Sean Carroll
Successful quality management for Software as a Medical Device (SaMD) will have 3 preeminent distinctives:

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part V - Trustworthy Devices (Cont'd)

April 1, 2019 | Posted by Ben Trombold
Welcome back to our continued breakdown of the new FDA Cybersecurity guidance. In this post, we will conclude our analysis of the “Trustworthy Devices” section of the document.
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