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Blog

Thought and Commentary for the Medical Device Industry

Static Analysis Regulations, Standards, & Best Practices

July 15, 2019 | Posted by Satyajit Ketkar
Welcome back to our series on Static & Dynamic Analysis, including Unit Testing. Our previous post provided a brief introduction to static analysis, what it is, and how it has developed. Today...

An Introduction to Human Factors Engineering for Medical Devices

July 11, 2019 | Posted by Mark Kraft
When it comes to medical device safety, having fully-integrated human factors engineering (HFE) processes in place throughout development is absolutely critical.

Introduction to Static Analysis

July 8, 2019 | Posted by Satyajit Ketkar
Regardless of industry, any company writing code understands the need for standardization and proof-checking, and the medical device sector is no different. What is different is the emphasis on...

Four Goals of a Valuable QMS

July 1, 2019 | Posted by Randy Armstrong
The principal objective of a QMS for a medical device company is patient safety. Patient safety is well understood and communicated throughout the medical device industry, leading to an almost...

Root of Trust #10 - Why BLE?

June 27, 2019 | Posted by Chris Gates
There are a large number of wireless solutions available, each with their own positive and negative attributes. Identifying the optimum wireless choice to employ for a given use case is critical...

Simple is Hard, but Simple is Worth it

June 24, 2019 | Posted by Randy Armstrong
In the second blog post in this series, we explained that a lean QMS results in less complicated devices, which in turn decreases development time, cost, and, in many cases, patient risk. Less is...