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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

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Blog

Thought and Commentary for the Medical Device Industry

A Summary of Medical Device Standards - Part III - Earning (And Keeping!) FDA Approval for Your Device

March 21, 2019 | Posted by Tim Carroll
FDA approval can be achieved in two ways: The 510(k) process, in which the manufacturer must provide evidence that the device they intend to market is “substantially equivalent” to a device...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part III - Trustworthy Devices

March 18, 2019 | Posted by Ben Trombold
Designing and developing trustworthy medical devices, according to the new FDA guidance on cybersecurity, will be our focus for the next two posts. 

A Summary of Medical Device Standards - Part II - Understanding CFR Part 820

March 14, 2019 | Posted by Tim Carroll
CFR Part 820, often referred to as simply Part 820, delineates the requirements for a quality management system that must govern the design and manufacture of any device sold in the United States....

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

March 11, 2019 | Posted by Ben Trombold
Our first topic concerns classification of medical devices according to the new FDA guidance. Two separate tiers of classification are described:

A Summary of Medical Device Standards - Part I - Know Your Bodies

March 7, 2019 | Posted by Tim Carroll
Federal standards governing the safety and efficacy of medical products have been overseen in the United States by the FDA since the original 1906 Food and Drugs Act. The approach to medical...

New FDA Pre-Market Submission Guidelines for Cybersecurity in Medical Devices - Part I - Introduction

March 5, 2019 | Posted by Ben Trombold
FDA 2016 Guidance on Cybersecurity within Medical Devices
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