We will be attending the 4th Annual Medical Device Cybersecurity Risk Mitigation conference in Arlington, VA on July 23rd and 24th! If you'd like to schedule a meeting, click the box in this banner!
Changing Lives for a Better World, One Device at a Time
What Separates Us from the Competition
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.
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++
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!
Mastering what you care about
elegance - speed - reduced risk
Simple is hard - and worth it
Devices can be designed in a number of ways - your system should require the minimum:
See things accomplished quickly
You deserve to see progress right away. With our teams, you can expect to see:
Manage risk from many places
There are lots of ways to design and develop. Our process and expertise reduces your exposure to:
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, ISO 27000 - Information Security Management
World Class Innovation in Medical Devices
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 process, designers can remove ambiguity from the product (formative studies) and developers can ensure the system can be used as intended (summative studies).
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).
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.
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.
Velentium has hired a robust team of engineers to ensure that all aspects of a system work in harmony with each other. With Velentium, you can be assured that the electronics, firmware, application software, and cloud components work seamlessly together.
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.
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.
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.
Velentium team members have experience developing Class III / Class C medical devices. As a result, we are very familiar with the unique challenges and considerations that go into medical device development. Velentium team members are subject matter experts in the fields of Information Security, Bluetooth Low Energy, embedded devices, cloud, mobile applications and test systems.