Velentium
Velentium Medical is a professional engineering firm based in the USA that designs and manufactures class II and class III medical devices. Their mission is to transform intellectual property into safe and secure products that can change lives for a better world. They offer end-to-end services including R&D, product development, contract manufacturing, and postmarket services, with a focus on security, compliance, and innovation in the medical device industry. They also specialize in embedded cybersecurity, providing comprehensive security planning, risk management, supply chain security, online training, security controls, testing, labeling, governance, and postmarket activities to ensure device safety and compliance.
Industries
Nr. of Employees
medium (51-250)
Velentium
7535 W Grand Parkway South, Richmond, TX 77407
Products
Test framework (test executive, secure storage, reporting)
A test framework combining a test executive, cybersecure storage, and reporting capabilities used across characterization, verification, and manufacturing testing.
Embedded cybersecurity masterclass (virtual)
On-demand training course that teaches regulatory-aligned embedded medical device cybersecurity practices and issues a professional certification upon completion.
Security requirements and controls whitepaper
Whitepaper summarizing foundational security requirements and associated controls applicable to connected medical device systems.
Test framework (test executive, secure storage, reporting)
A test framework combining a test executive, cybersecure storage, and reporting capabilities used across characterization, verification, and manufacturing testing.
Embedded cybersecurity masterclass (virtual)
On-demand training course that teaches regulatory-aligned embedded medical device cybersecurity practices and issues a professional certification upon completion.
Security requirements and controls whitepaper
Whitepaper summarizing foundational security requirements and associated controls applicable to connected medical device systems.
Services
Onshore manufacturing for prototype, preclinical, clinical, and commercial production of Class II and Class III devices, including sterile packaging, fulfillment, and postmarket services.
Consulting and engineering across systems, electrical, firmware, mechanical, RF, usability, and software to bring devices from concept through transfer to manufacturing, including support for regulatory documentation.
Security engineering services covering threat modeling, security plans, SBOM generation and management, cryptographic design, security testing, governance/policy drafting, premarket artifact generation, and subscription-based postmarket monitoring and incident response support.
Virtual, self-paced masterclass that trains engineering teams on medical device cybersecurity requirements, testing methods, and submission-ready artifact creation; includes certification and continuing education options.
Design and build of test frameworks and scalable hardware/software test systems for characterization, design verification, manufacturing test, and returned product analysis with cybersecure data handling.
Onshore manufacturing for prototype, preclinical, clinical, and commercial production of Class II and Class III devices, including sterile packaging, fulfillment, and postmarket services.
Consulting and engineering across systems, electrical, firmware, mechanical, RF, usability, and software to bring devices from concept through transfer to manufacturing, including support for regulatory documentation.
Security engineering services covering threat modeling, security plans, SBOM generation and management, cryptographic design, security testing, governance/policy drafting, premarket artifact generation, and subscription-based postmarket monitoring and incident response support.
Virtual, self-paced masterclass that trains engineering teams on medical device cybersecurity requirements, testing methods, and submission-ready artifact creation; includes certification and continuing education options.
Design and build of test frameworks and scalable hardware/software test systems for characterization, design verification, manufacturing test, and returned product analysis with cybersecure data handling.
Expertise Areas
- Medical device research and development
- Contract manufacturing for Class II/III and active implantables
- Embedded medical device cybersecurity lifecycle management
- Premarket submission artifact preparation and regulatory alignment
Key Technologies
- Embedded firmware
- Over-the-air firmware update (FOTA)
- Bluetooth Low Energy (BLE)
- Medical-band radio communications
News & Updates
Discover the 7 critical pitfalls to avoid when partnering with a contract manufacturer for your medical device, including quality and supply chain stability.
Learn how to create an effective budget for your medtech startup, a crucial step for success, from Velentium Medical's webinar.
Guidance on aligning funding strategies with each stage of medical device development to de-risk startups and accelerate market entry.
Insights into key reimbursement challenges in the medtech industry to ensure market success.
Discussion on connection safety, efficacy, and holistic research and development in medical device cybersecurity.
An exploration of the complexities in designing, developing, and manufacturing medical devices, emphasizing the non-linear nature of the process.
Discover the 7 critical pitfalls to avoid when partnering with a contract manufacturer for your medical device, including quality and supply chain stability.
Learn how to create an effective budget for your medtech startup, a crucial step for success, from Velentium Medical's webinar.
Guidance on aligning funding strategies with each stage of medical device development to de-risk startups and accelerate market entry.
Insights into key reimbursement challenges in the medtech industry to ensure market success.
Discussion on connection safety, efficacy, and holistic research and development in medical device cybersecurity.
An exploration of the complexities in designing, developing, and manufacturing medical devices, emphasizing the non-linear nature of the process.