Medical Device Cybersecurity

Humanizing and Simplifying Product Security for Medical Device Manufacturers and Engineers

Our Service Offerings

Product Security Governance

Product Security Governance

Premarket Cybersecurity

Premarket Cybersecurity

Vulnerability & Penetration Testing

Vulnerability & Penetration Testing

Postmarket Cybersecurity

Postmarket Cybersecurity

Cybersecurity Training

Security Awareness & Training

Velentium Medical's cybersecurity team covers all aspects of medical device product security - we are here to help you rapidly bring a secure product to market, from napkin to user through end of support.

We can provide every activity and document as required by global cybersecurity guidance for device submissions and long-term sustaining efforts.

Governance

Policies and procedures incorporated into your QMS compliant with global standards and regulations.

Security Planning

Security risk management planning for the total product life cycle, from requirements through end of life.

Security Requirements

Support with system and product / specification level security requirements that are traceable and testable.

Secure Design & Architecture

Threat modeling of assets and processes with crafted controls, risk assessments, and security architecture views.

Third-Party & Supply Chain

Software Bill of Materials (SBOM) with vulnerability analyses, support information, and vendor assessments.

Cybersecurity Metrics

Metrics to be gathered during update and patch events, provided as a required eSTAR artifact.

Cybersecurity Labeling

Content to be added to the IFU and user manual for transparency to end users.

Security Testing

System-wide vulnerability testing and penetration testing by qualified experts with independence.

Unresolved Anomalies

Security assessments of software bugs following Verification and Validation activities.

Reporting & Traceability

Submission-ready artifacts to be included in the DHF according to our templates and compliant with global expectations.

Postmarket Compliance

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.

Contact us today to secure your device.

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.

Garrett Schumacher

Garrett Schumacher

Business Unit Leader

Product Security

Read More →

Safe. Secure. Effective.

One stop for secure Medical Device R&D, product development, contract

manufacturing, and postmarket services

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