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.
Integrate and analyze your software supply chain to identify and mitigate vulnerabilities.
Encrypt data, manage devices, and streamline incident response.
Benchmark your product security posture, quantify financial risk, and prioritize mitigation with clear budget insights to accelerate approvals and build trust.
Navigate cybersecurity compliance for your 510(k) submissions or pre-market approval (PMA) with ease.
How to navigate your EU Medical Device Regulation submissions.
How to navigate your Health Canada submissions.
We identify gaps in your PKI and certificate management practices and create an actionable mitigation strategy.
Automated cryptographic provisioning for a radiotherapy system — FDA-compliant encrypted communication without costly redesigns.
Plug-and-play security for a 3D mapping system — achieving FDA compliance & modern encryption while preserving regulatory approvals.
Secured three surgical devices with different manufacturers — preventing unauthorized attachments while maintaining FDA clearances and performance.
Scalable authentication for a device hub serving multiple teams — centralizing certificate management while meeting FDA expectations.
See how Helm eliminates the false positive problem plaguing vulnerability management tools. Side-by-side comparison against Grype, Dependency Track, and Blackduck.
How to navigate your EU Medical Device Regulation submission
Our products are optimized for medical device manufacturers to build secure, innovative medical devices faster while meeting FDA cybersecurity requirements
Regulatory strategy, penetration testing, threat modeling, and process optimization for FDA readiness.
Accelerate FDA approval with expert guidance, including FDA cybersecurity readiness, threat modeling, PKI analysis, maturity assessments, and SDLC integration
Maintain patient safety and regulatory complianceIncluding incident response, vulnerability management, risk management, SBOM validation, and compliance updates
Get secure medical devices to market on schedule with peace of mind.
Identify gaps and create prioritized plans to meet FDA requirements.
Immediate guidance to navigate your response process.
Protect your software ecosystem with continuous security improvements.
10-minute diagnostic transformed fragmented security into enterprise-wide visibility.
Risk analysis secured $1M+ investment by quantifying ROI.
Encryption reviews and threat modeling for surgical robotics, avoiding costly delays.
Remediated major deficiencies efficiently while controlling costs.
Automated SBOM analysis and reduced review time by 90%.
