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).
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.
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.
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.
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
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Insights & Testimonials
Hear First Hand from Our Team
Mamoru KanazawaSr. 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 JensenSr. 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 JoslinDirector 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
Thought and Commentary for the Medical Device Industry
Is your team prepared for cybersecurity threats and the evolving focus from the FDA? Most medical device manufacturers and software teams find this topic uncomfortable - and rightly so. Many of us...
Project V had so many moving pieces, it was hard to capture it all in a single narrative. To help us tell the story, we partnered with 2448 Productions. Here's the result:Short version (1:40)
