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Assistance Throughout All Stages of Your Medical Device Lifecycle

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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Why Partner with Us

Simple Elegance

Simple is hard, but simple is worth it

Your device should be as intuitive as possible – minimalistic yet complete.

Rapid Milestones

See goals accomplished quickly

You deserve to see progress right away. You will experience weekly demos, daily access, and status transparency.

Reduced Risk

Protecting you and your patients

Our process and expertise reduces patient risk, technical risk, and business risk.

Secure Development

Cybersecure from beginning to end

Our secure development process assures the we are solving cybersecurity challenges throughout your project.

Quality Driven

Certified to: ISO 13485 – Quality Management Systems
Compliant with: 
ISO 14971 - Risk Management, IEC 62304 - Software

IEC 60601 - Electrical, ISO 62366 - Usability, ISO 14708 – Active Implantables

ISO 13485:2016 Certificate of Registration
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How Can We Help You Reach Your Goals?

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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:
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