HISAC

Solutions

Solutions 2

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

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.

SBOM VULNERABILITY MGMT CASE STUDY

Competitive analysis: Helm vs. leading tools

See how Helm eliminates the false positive problem plaguing vulnerability management tools. Side-by-side comparison against Grype, Dependency Track, and Blackduck.

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

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

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