Design & Development

ONE-STOP SHOP FOR END-TO-END MEDICAL DEVICE DESIGN AND DEVELOPMENT.

Design &

Development

Velentium's consulting and contract design team specializes in the development, production, and postmarket support of diagnostic and therapeutic active medical devices, especially implantables and wearables for neuromodulation and other Class III indications.

Learn more about Velentium's holistic approach to medical device development. Tap below to access From Concept to Commercialization: The Medical Device Development Playbook.

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Our Areas of Expertise Include:

Electrical Design
Mechanical Design
Firmware & Software
Software As a Medical Device (SaMD)
Mobile Apps & Integrations (iOS & Android)
Embedded / OT / IoT Cybersecurity
Systems Engineering
Human Factors; Usability

Choose Velentium for:

End-to-end solutions and consulting for secure design, development, production, and postmarket
Decades of experience = accelerated development
Better questions asked earlier to ensure your success
Contracts tailored to match your needs

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Meet Our Experts

Consulting and engineering solutions for "impossible" tech. Helping you turn apparent sci-fi into life-changing reality.

Randy Armstrong

CTO

Chris Jensen

VP, Technology

Human Factors Engineering

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).

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).

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

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.

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.

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.

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.

Mobile
Apps

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

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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Quality Driven

ISO 13485 Certified

Not only do we follow the standards, we helped write them! Intelligent, efficient, compliance.

Download ISO 13485 Certificate

Certified:

ISO 13485 – Quality Management Systems

Compliant:

ISO 14971 - Risk Management

IEC 62304 - Software

IEC 60601 - Electrical

IEC 62366 - Useability

ISO 14708 - Active Implantables

ISO 27001 - Information Security Management

Your IP: Designed & Built

Design & Development

Contract Manufacturing

Design &
Development

Embedded Cybersecurity

Automated Test Systems

Our Services:

Design &