MedCrypt provides a cybersecurity platform that includes SBOM and vulnerability management tools to help medical device manufacturers meet FDA compliance requirements. Their services ensure secure device management and ongoing monitoring, addressing the risks of data breaches and regulatory delays in the medical device industry.
Funding
$34.4M raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
+3Founders
Product
Problem
Medical device manufacturers face increasing pressure to meet stringent FDA cybersecurity requirements, which can delay market entry and increase costs. Ensuring devices are secure by design and continuously monitored for vulnerabilities is a complex and resource-intensive process. Failure to comply with FDA guidelines can lead to regulatory delays, data breaches, and compromised patient safety.
Solution
Medcrypt provides a comprehensive cybersecurity platform and expert services designed to help medical device manufacturers navigate FDA compliance and secure their devices throughout their lifecycle. The platform includes tools for SBOM (Software Bill of Materials) management, vulnerability detection, and remediation, offering full visibility across the software supply chain. Medcrypt's Guardian platform enables secure device provisioning and certificate/key management, while Canary captures device behavior data for real-time monitoring of potential security incidents, even for devices with limited connectivity. By automating security processes and providing expert guidance, Medcrypt helps manufacturers accelerate FDA submissions, maintain a strong security posture, and deliver safe and effective technologies to patients.
Target Audience
Medcrypt primarily serves medical device manufacturers, ranging from startups to enterprise-level organizations, who need to meet FDA cybersecurity requirements and ensure the security of their connected devices.
Features
- **Helm:** SBOM and vulnerability management tool providing full visibility across the medical device software supply chain to detect, prioritize, and remediate cybersecurity risks.
- **Guardian:** Platform for building devices that are secure by design, automating device provisioning, and managing certificates/keys.
- **Canary:** Solution for capturing medical device behavior data, providing visibility into potential security-related incidents, even for devices with limited connectivity.
- **FDA Cybersecurity Readiness Services:** Regulatory strategy, penetration testing, threat modeling, and process optimization to prepare for FDA cybersecurity requirements.
- **FDA Cybersecurity Filing Remediation:** Identification of gaps and creation of a prioritized plan to rectify issues, ensuring compliance with FDA requirements.
- **Threat Modeling:** Services to protect the software ecosystem and incorporate continuous security improvements into processes.
- **Cryptography Design and Review:** Identification of gaps in PKI and certificate management practices, with creation of an actionable mitigation strategy.