Whitepaper

Medcrypt Helm: Intelligent & Automated SBOM Vulnerability Management

Overview:

Executive summary

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Executive summary

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Solutions

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Get the Medcrypt advantage with our expert team of FDA and medical device experts to prepare for FDA cybersecurity readiness via regulatory strategy, penetration testing, threat modeling, process optimization, and more.

PRODUCTS

SBOM & vulnerability management

Integrate and analyze your software supply chain to identify and mitigate vulnerabilities.

Data security & privacy

Encrypt data, manage devices, and streamline incident response.

End-to-end cybersecurity roadmap

Benchmark your product security posture, quantify financial risk, and prioritize mitigation with clear budget insights to accelerate approvals and build trust.

Cybersecurity incident response
Vulnerability management & patch strategy development
Cybersecurity risk management
SBOM validation & monitoring
Regulatory change management & compliance updates

REGULATORY BODiES

Regulatory bodies

FDA

Navigate cybersecurity compliance for your 510(k) submissions or pre-market approval (PMA) with ease.

EU MDR

How to navigate your EU Medical Device Regulation submissions.

Health Canada

How to navigate your Health Canada submissions.

Cryptography design and review

We identify gaps in your PKI and certificate management practices and create an actionable mitigation strategy.

CRYPTO CASE STUDIES

Secure communication — no re-engineering

Automated cryptographic provisioning for a radiotherapy system — FDA-compliant encrypted communication without costly redesigns.

Legacy systems — no source code changes

Plug-and-play security for a 3D mapping system — achieving FDA compliance & modern encryption while preserving regulatory approvals.

Diverse tech stacks, unified security

Secured three surgical devices with different manufacturers — preventing unauthorized attachments while maintaining FDA clearances and performance.

Future-proof growing device ecosystems

Scalable authentication for a device hub serving multiple teams — centralizing certificate management while meeting FDA expectations.

Cryptography design and review

We identify gaps in your PKI and certificate management practices and create an actionable mitigation strategy.

REGULATORY BODiES

FDA

Navigate cybersecurity compliance for your 510(k) submissions or pre-market approval (PMA) with ease.

EU MDR

How to navigate your EU Medical Device Regulation submission

Health Canada

How to navigate your Health Canada submissions.

Solutions

Our products are optimized for medical device manufacturers to build secure, innovative medical devices faster while meeting FDA cybersecurity requirements

SOLUTIONS

Products

SBOM & vulnerability management

Integrate and analyze your software supply chain to identify and mitigate vulnerabilities.

Data security & privacy

Encrypt data, manage devices, and streamline incident response.

End-to-end cybersecurity roadmap

Benchmark your product security posture, quantify financial risk, and prioritize mitigation with clear budget insights to accelerate approvals and build trust.

REGULATORY BODiES

Regulatory bodies

FDA

Navigate cybersecurity compliance for your 510(k) submissions or pre-market approval (PMA) with ease.

EU MDR

How to navigate your EU Medical Device Regulation submissions.

Health Canada

How to navigate your Health Canada submissions.

Cryptography design and review

We identify gaps in your PKI and certificate management practices and create an actionable mitigation strategy.

Pricing

Services

SECURE DEVICE LIFECYCLE

RESOURCES

Blog Case studies FDA compliance Whitepapers Webinars & conferences Webinars Events

DOCUMENTATION

Helm docs Guardian docs

Company

About us DEIB How we contribute Careers News Webinars Events

Medcrypt Helm: Intelligent & Automated SBOM Vulnerability Management

Executive summary

Executive summary

SBOM & vulnerability management

Data security & privacy

End-to-end cybersecurity roadmap

FDA

EU MDR

Health Canada

Cryptography design and review

Secure communication — no re-engineering

Legacy systems — no source code changes

Diverse tech stacks, unified security

Future-proof growing device ecosystems

Cryptography design and review

FDA

EU MDR

Health Canada

SBOM & vulnerability management

Data security & privacy

End-to-end cybersecurity roadmap

FDA

EU MDR

Health Canada

Cryptography design and review

All services

Pre-market services

Post-market services

FDA cybersecurity readiness

FDA cybersecurity filing remediation

FDA hold letter response

Threat modeling

100+ device security assessment

Secure connectivity business case

Encryption architecture assessment

Cardiac device PMA remediation

Vulnerability management

Cryptography design and review