Velentium Medical
Engineering-led contract development and manufacturing organization (CDMO) providing end-to-end medical device product development, device cybersecurity, contract manufacturing (prototype through commercial), and automated test systems. Operates integrated teams for systems, electrical, mechanical, firmware, human factors, regulatory and quality in FDA-registered facilities. Supports Class II–III devices, regulatory submissions, postmarket compliance, and commercialization scale-up.
Industries
Nr. of Employees
medium (51-250)
Services
Consulting and engineering services spanning systems engineering, mechanical/electrical/firmware design, human factors, verification/validation, and regulatory support.
Product security governance, cybersecurity artifact generation for premarket submissions, vulnerability and penetration testing, postmarket monitoring, incident response, and related advisory services.
Onshore FDA-registered contract manufacturing with options for low-cost regions, cleanroom assembly, sterile packaging, fulfillment, and returned product analysis.
Design and delivery of capital equipment test systems for characterization, design verification & validation, and manufacturing test with secure data handling.
Virtual, self-paced training for engineers covering regulatory requirements, testing methodologies, SBOMs, threat modeling, and cryptography with certification options.
Published podcasts, blog posts, webinars and whitepapers addressing medical device development, cybersecurity, regulatory topics and commercialization.
Consulting and engineering services spanning systems engineering, mechanical/electrical/firmware design, human factors, verification/validation, and regulatory support.
Product security governance, cybersecurity artifact generation for premarket submissions, vulnerability and penetration testing, postmarket monitoring, incident response, and related advisory services.
Onshore FDA-registered contract manufacturing with options for low-cost regions, cleanroom assembly, sterile packaging, fulfillment, and returned product analysis.
Design and delivery of capital equipment test systems for characterization, design verification & validation, and manufacturing test with secure data handling.
Virtual, self-paced training for engineers covering regulatory requirements, testing methodologies, SBOMs, threat modeling, and cryptography with certification options.
Published podcasts, blog posts, webinars and whitepapers addressing medical device development, cybersecurity, regulatory topics and commercialization.
Expertise Areas
- Medical device product development and systems engineering
- Medical device cybersecurity and SBOM management
- Contract manufacturing and sterile manufacturing operations
- Automated test systems design and manufacturing test
Key Technologies
- Embedded firmware with FOTA
- Mobile medical software (iOS/Android)
- Bluetooth Low Energy (BLE)
- MedRadio and inductive communications
News & Updates
Industry conference appearance listed as upcoming events.
Discussion of secure design and architecture practices for medical device cybersecurity.
Explains how software bill of materials (SBOMs) support supply chain oversight and vulnerability management for medical devices.
Guidance on communicating security-related information to clinicians and IT administrators through labeling.
Approach to identifying and mitigating cybersecurity risks during device design to avoid embedded vulnerabilities and support regulatory compliance.
Framework describing tiered classifications for selecting cryptographic primitives and configurations in medical device systems.
Industry conference appearance listed as upcoming events.
Discussion of secure design and architecture practices for medical device cybersecurity.
Explains how software bill of materials (SBOMs) support supply chain oversight and vulnerability management for medical devices.
Guidance on communicating security-related information to clinicians and IT administrators through labeling.
Approach to identifying and mitigating cybersecurity risks during device design to avoid embedded vulnerabilities and support regulatory compliance.
Framework describing tiered classifications for selecting cryptographic primitives and configurations in medical device systems.