Medcrypt
Medical device cybersecurity platform offering SBOM and vulnerability management (Helm).
medical device cybersecurity: 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.
Benchmark your product security posture, quantify financial risk, and prioritize mitigation with clear budget insights to accelerate approvals and build trust.
About
**Who they are**
Medcrypt is a medical device cybersecurity provider focused on helping manufacturers navigate complex regulatory landscapes and secure their products. They leverage expertise in FDA regulations and medical device cybersecurity to prepare companies for market approval and ongoing compliance.
**Expertise & scope**
* FDA cybersecurity readiness and regulatory strategy
* Penetration testing, threat modeling, and process optimization
* Software supply chain analysis for vulnerability identification and mitigation
* Data encryption, device management, and incident response streamlining
* Product security posture benchmarking and risk quantification
* SBOM validation and monitoring
* Regulatory change management and compliance updates
* Support for 510(k) submissions and pre-market approval (PMA)
**Reputation / proof points**
* Focus on achieving FDA cybersecurity readiness
* Expert team of FDA and medical device cybersecurity specialists
Medcrypt is a medical device cybersecurity provider focused on helping manufacturers navigate complex regulatory landscapes and secure their products. They leverage expertise in FDA regulations and medical device cybersecurity to prepare companies for market approval and ongoing compliance.
**Expertise & scope**
* FDA cybersecurity readiness and regulatory strategy
* Penetration testing, threat modeling, and process optimization
* Software supply chain analysis for vulnerability identification and mitigation
* Data encryption, device management, and incident response streamlining
* Product security posture benchmarking and risk quantification
* SBOM validation and monitoring
* Regulatory change management and compliance updates
* Support for 510(k) submissions and pre-market approval (PMA)
**Reputation / proof points**
* Focus on achieving FDA cybersecurity readiness
* Expert team of FDA and medical device cybersecurity specialists
Additional information
Medcrypt's services are designed to integrate into the medical device lifecycle, addressing cybersecurity needs from development through post-market surveillance. They emphasize proactive measures such as threat modeling and SBOM management to identify and mitigate vulnerabilities early. Their approach aims to quantify financial risk and provide clear budget insights, facilitating faster approvals and building trust with regulatory bodies. They also offer support for responding to FDA requests for additional information and addressing regulatory requirements.
Key Highlights
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Offers a medical device cybersecurity platform with SBOM and vulnerability management.
Source
“Medical device cybersecurity platform offering SBOM and vulnerability management (Helm).”
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Provides expert guidance for FDA cybersecurity readiness, including regulatory strategy and penetration testing.
Source
“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.”
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Assists with navigating cybersecurity compliance for 510(k) submissions and pre-market approval (PMA).
Source
“Navigate cybersecurity compliance for your 510(k) submissions or pre-market approval (PMA) with ease.”
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Focuses on integrating and analyzing software supply chains to identify and mitigate vulnerabilities.
Source
“Integrate and analyze your software supply chain to identify and mitigate vulnerabilities.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA cybersecurity compliance.
- Companies needing to integrate SBOM and vulnerability management.
- Organizations requiring expert guidance on regulatory strategy.
How engagement typically works
- Consultative approach with expert guidance.
- Focus on regulatory strategy and readiness.
- Partnership for product lifecycle security.
Typical deliverables
- Regulatory strategy and submission support.
- Threat modeling reports and roadmaps.
- Vulnerability management plans.
- SBOM validation and monitoring.
- Cybersecurity risk assessments.
Good to know
- Best when preparing for FDA 510(k) or PMA submissions.
- Ideal for devices with complex software supply chains.
- Most effective when engaging early in the product development lifecycle.
Pricing
Model:
Per SKU
Public range:
Publicly listed: $1 - $32,000
Notes:
Based on publicly listed information; final fees depend on scope and package selected.
“Pricing: $1; $299 per month; $32,000”
Claim status:
Listed
Services & Capabilities
Medical Device Cybersecurity
Provider Type:
Both
Service Categories:
Penetration Testing (Manual/Hardware), SBOM Management (Software Tool), Threat Modeling & Risk Analysis, Vulnerability Management (Post-Market)
Sbom Formats Supported:
CycloneDX, SPDX
Sbom Management Available:
Yes
Vulnerability Monitoring Available:
Yes
Submission Stage Support:
Ready for 510(k)/MDR Submission
Device Types Supported:
Software as a Medical Device (SaMD), Connected Hardware (IoT/WiFi/Bluetooth)
Standards Frameworks:
FDA, EU Medical Device Regulation, Health Canada
Pen Testing Available:
Yes
Threat Modeling Available:
Yes
cbam_verification
Additional medical_device_cybersecurity Details
Provider Type
Both
Service Categories
SBOM Management, Threat Modeling, Vulnerability Management
Submission Stage Support
Pre‑Submission, Ready for 510(k)/MDR
Device Types Supported
SaMD, connected hardware
Standards Frameworks
NIST
