Humanizing and Simplifying Product Security for Medical Device Manufacturers and Engineers
Policies and procedures incorporated into your QMS compliant with global standards and regulations.
Security risk management planning for the total product life cycle, from requirements through end of life.
Support with system and product / specification level security requirements that are traceable and testable.
Threat modeling of assets and processes with crafted controls, risk assessments, and security architecture views.
Software Bill of Materials (SBOM) with vulnerability analyses, support information, and vendor assessments.
Metrics to be gathered during update and patch events, provided as a required eSTAR artifact.
Content to be added to the IFU and user manual for transparency to end users.
System-wide vulnerability testing and penetration testing by qualified experts with independence.
Security assessments of software bugs following Verification and Validation activities.
Submission-ready artifacts to be included in the DHF according to our templates and compliant with global expectations.
Sustaining DMR/DHR review, periodic testing, SBOM & other monitoring, COTS device administration, and incident response & disclosure support.
Bolster in-house capabilities with 3 levels of training for executives, quality & regulatory, and developers & engineers.
Flexible Cybersecurity Services for Every Need
We adapt our services to your project’s scope, team size, and budget. Whether you need targeted guidance, collaborative support, or a fully outsourced security division, we’ll meet you where you are.
Wherever you are in your product life cycle, we can help.
Meet Our Experts
With decades of safety-critical cybersecurity experience, Velentium Medical offers best-in-class product security services. Learn from our experts by visiting our Resource Center.
Safe. Secure. Effective.
One stop for secure Medical Device R&D, product development, contract
manufacturing, and postmarket services
Who We Are
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