Cybersecurity Quick Scan for MedTech

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• Growing Cyber Threat Landscape: Connected medical devices are increasingly targeted by cyber threats. A proactive approach is necessary to minimize potential vulnerabilities.
• IEC 81001-5-1 Compliance Required as of January 2025: The transition period ends in December 2024, making compliance mandatory from January 2025.
• Avoiding Non-Conformities and Delays: Compliance helps avoid costly and time-consuming non-conformities in audits (ISO 13485/MDSAP) and prevents market entry delays caused by cybersecurity gaps in technical documentation.

The Quick Scan is a cost-effective and structured way to assess your cybersecurity posture. It helps you prepare for 2025 with confidence, providing either peace of mind knowing your device meets compliance standards or a clear action plan to address gaps.

• Evaluate current security measures against the latest harmonized standards.
• Review existing technical documentation comprehensively.
• Identify controls and defenses against cybersecurity risks.
• Provide actionable recommendations to close security gaps.
• Conduct vulnerability scanning, including software and network assessments, to identify weaknesses.

You will receive a comprehensive evaluation report assessing your medical device (or software) against the latest harmonized standards (EU/USA/IEC 81001-5-1). The report will identify risks and vulnerabilities and provide actionable recommendations to address these cybersecurity risks effectively.

For small to medium companies, the Quick Scan will typically take between 2–4 days. 

All manufacturers of connected medical devices, especially those preparing for IEC 81001-5-1 compliance.