Medcrypt
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 regulatory compliance and enhance product security. They leverage a team of FDA and medical device experts to prepare companies for FDA cybersecurity readiness.
**Expertise & scope**
* Regulatory strategy and compliance for 510(k) submissions and pre-market approval (PMA).
* Software supply chain integration and analysis to identify and mitigate vulnerabilities.
* SBOM validation and monitoring.
* Vulnerability management and patch strategy development.
* Cybersecurity risk management and benchmarking product security posture.
* Penetration testing, threat modeling, and cryptography design review.
* Incident response and device management.
* Addressing FDA requests for additional information.
**Reputation / proof points**
* Offers services to prepare for FDA cybersecurity readiness.
* Aims to accelerate approvals and build trust through clear budget insights and risk quantification.
* Focuses on addressing risk and uncertainty for device commercialization and meeting regulatory requirements.
Medcrypt is a medical device cybersecurity provider focused on helping manufacturers navigate regulatory compliance and enhance product security. They leverage a team of FDA and medical device experts to prepare companies for FDA cybersecurity readiness.
**Expertise & scope**
* Regulatory strategy and compliance for 510(k) submissions and pre-market approval (PMA).
* Software supply chain integration and analysis to identify and mitigate vulnerabilities.
* SBOM validation and monitoring.
* Vulnerability management and patch strategy development.
* Cybersecurity risk management and benchmarking product security posture.
* Penetration testing, threat modeling, and cryptography design review.
* Incident response and device management.
* Addressing FDA requests for additional information.
**Reputation / proof points**
* Offers services to prepare for FDA cybersecurity readiness.
* Aims to accelerate approvals and build trust through clear budget insights and risk quantification.
* Focuses on addressing risk and uncertainty for device commercialization and meeting regulatory requirements.
Additional information
Medcrypt's services are designed to integrate into the medical device lifecycle, from development through commercialization. They emphasize quantifying financial risk and prioritizing mitigation efforts to streamline the approval process. Their approach includes analyzing the software supply chain to identify and address vulnerabilities, which is crucial for meeting evolving FDA cybersecurity expectations. Buyers can expect support in navigating complex regulatory landscapes, including responding to FDA requests for additional information and ensuring ongoing compliance.
Key Highlights
-
Provides expert team of FDA and medical device experts for cybersecurity readiness.
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.”
-
Offers SBOM validation and monitoring services.
Source
“SBOM validation & monitoring”
-
Specializes in vulnerability management and patch strategy development.
Source
“Vulnerability management & patch strategy development”
-
Supports navigation of 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.”
Certifications & Trust Signals
-
Focuses on addressing risk and uncertainty for device commercialization to meet regulatory requirements.
Source
“Addresses: address risk and uncertainty for device commercialization and to meet regulatory requirements and guidelines”
-
Aims to benchmark product security posture and quantify financial risk.
Source
“Benchmark your product security posture, quantify financial risk, and prioritize mitigation with clear budget insights to accelerate approvals and build trust.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA cybersecurity readiness.
- Companies needing to navigate 510(k) or PMA submissions.
- Organizations looking to manage software supply chain vulnerabilities.
How engagement typically works
- Consultative approach to regulatory strategy.
- Focus on actionable roadmaps and process optimization.
- Expert guidance on threat modeling and risk management.
Typical deliverables
- SBOM validation reports.
- Vulnerability management plans.
- Threat modeling documentation.
- Regulatory compliance strategies.
- Penetration testing reports.
Good to know
- Best when seeking specialized expertise in medical device cybersecurity and FDA compliance.
Pricing
Model:
Per SKU
Public range:
Publicly listed: $1 - $32,000
Notes:
Based on publicly listed information; final fees depend on scope.
“$1; $299 per month; $32,000”
HQ:
USA
Languages:
English
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
connected hardware
Standards Frameworks
IEC 81001-5-1, ISO 14971, NIST
