Medcrypt

The product is a SaaS platform for medical device cybersecurity compliance that helps manufacturers meet FDA, EU MDR, and Health Canada requirements, prepare submissions, manage SBOMs and vulnerabilities, and maintain post-market compliance. It sells to medical device manufacturers including enterprise and mid-market product, engineering, and regulatory teams responsible for 510(k) and PMA submissions. It is delivered as a single platform combining software tools, data, and expert support from former FDA reviewers across readiness scoring, remediation, and ongoing monitoring.

Key features

• SBOM and vulnerability management
• SBOM validation and monitoring
• Automated SBOM analysis
• Vulnerability monitoring and alerts
• Vulnerability management and patch strategy
• Cybersecurity risk management
• Cybersecurity incident response
• Data security and privacy
• Data encryption and device management
• Cryptography design and review
• PKI and certificate management
• Threat modeling
• Penetration testing
• Regulatory change management and updates
• Automated self-audits
• FDA submission readiness scoring