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 manufacturing of
therapeutic and diagnostic active medical devices.

Recent FDA guidance has magnified the importance of HFE. With HFE, designers can remove ambiguity from the product (formative studies) and developers can ensure the system can be used as intended (summative studies).

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Embedded Cybersecurity

Velentium utilizes a Secure Development Lifecycle. We believe the best way to ensure a secure system is to weave security throughout the entire development process (similar to risk management per ISO 14971 and harmonized with IEC 62304). Christopher Gates, our SME on Cybersecurity contributed to the FDA's pre and post-market cybersecurity guidance. He is also involved with the medical device expert group for the BLE SIG (special interest group).

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Automated Test Systems

Our team members have been developing test systems for medical devices for over 25 years. Our test systems are used in system characterization, design verification, manufacturing test, and returned product analysis. Often, the same equipment and software can be used throughout the testing lifecycle - allowing savings and certainty of the test method.

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Electrical Design

Our electrical team has designed systems with near-field (inductive) and far-field communications (BLE, MedRadio). We have worked with a variety of micro-controllers and can assist with ASIC specifications. Altium is our software of choice, however, we can adapt to any special request and are familiar with a variety of other options. Our SMEs have designed numerous medical devices, including 30+ active implantable devices.

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Systems Engineering

It is the intersection of technologies that often causes projects to fall behind or never work. With Velentium, you can be assured that the electronics, firmware, application software, and cloud components work seamlessly together.

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Mechanical Design

Our team members have extensive mechanical design experience on active implantables and leads. We also design device peripherals, device fixtures, and complex tooling. The majority of our work is in SolidWorks and OnShape.

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Firmware

Our team is specialized in firmware for Class 2 and 3 devices, including neurostimulators, active implantables, pacemakers, LVADs, and ICDs. Our embedded systems implement communication schemes that are compliant with FDA Cybersecurity guidance. Our blend of firmware and cloud expertise enables us to implement firmware over-the-air (FOTA) in a safe and secure manner.

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Mobile Apps

Our development adheres to ISO 13485 and to IEC 62304 - differentiating our medical app development from that of a generic app firm.

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Cloud-Based Applications

We create cloud solutions using a secure development process surrounding data as it is moved from an office to the cloud, and between patient and clinician applications. Our blend of cloud and firmware expertise enables us to implement firmware over-the-air (FOTA) in a safe and secure manner.

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Why Partner with Us

Simple Elegance

Simple is hard - and worth it

Devices can be designed in a number of ways - your system should require the minimum:

Parts
Power
Training

Rapid Milestones

See things accomplished quickly

You deserve to see progress right away. With our teams, you can expect to see:

Weekly demos
Daily access
Budgeted pivots
Transparency

Reduced Risk

Manage risk from many places

There are lots of ways to design and develop. Our process and expertise reduces your exposure to:

Patient risk
Technical risk
Business risk

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

ISO 13485 Certified

Not only do we follow the standards, we helped write them! We adhere to them smartly – with compliant efficiency.

Download ISO 13485 Certificate

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, ISO 27000 - Information Security Management

How Can We Help You Reach Your Goals?

Insights & Testimonials

Hear First Hand from Our Team

Mamoru Kanazawa Sr. Mobile Developer

In the fast-paced industry of medical devices, Velentium is a company where you can gain valuable experience in a vast array of projects as well as learn from and work with some of the most passionate and talented engineers in their field. Velentium not only focuses on changing the lives of patients, but its employees as well.

Chris Jensen Sr. Technical Lead

Velentium has a collaborative and welcoming culture that is unlike any other I have experienced throughout my career. On a day to day basis, I am surrounded by and actively work with high performing individuals that are not only trustworthy, but supportive. Even more prominent is the strong ethical foundation that guides every aspect of the business and is reinforced constantly through the demonstration and celebration of our 3 core values: Honorable, Results++, and Humble Charisma.

Jessica Joslin Director of Finance

It is the culture at Velentium that makes the biggest difference to me. At Velentium, character, honesty and integrity are valued, and I contribute as a whole person not just for the job I do. We all work together as a team and that makes working here a joy.

Blog

Assistance Throughout All Stages of Your Medical Device Lifecycle

Velentium is a professional engineering firm, specializing in the design and manufacturing of therapeutic and diagnostic active medical devices.

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

Why Partner with Us

Simple Elegance

Simple is hard - and worth it

Rapid Milestones

See things accomplished quickly

Reduced Risk

Manage risk from many places

Simple Elegance

Simple is hard, but simple is worth it

Rapid Milestones

See goals accomplished quickly

Reduced Risk

Protecting you and your patients

Secure Development

Cybersecure from beginning to end

ISO 13485 Certified

How Can We Help You Reach Your Goals?

Hear First Hand from Our Team

Thought and Commentary for the Medical Device Industry

5 Updates Pending to the FDA's Cybersecurity for Premarket Submissions

Transformational Leadership - Optimism Precedes Recognition

Transformational Leadership - Integrated Communication

Transformational Leadership - Honorable

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Featured Blog Posts

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Velentium, LLC

VMF - Manufacturing Facility

Velentium is a professional engineering firm,
specializing in the design and manufacturing of
therapeutic and diagnostic active medical devices.