As New Zealand’s healthcare sector rapidly adopts cloud-based medical software, connected devices, and digital workflows, ensuring robust cybersecurity is now a mandatory requirement—not just a best practice. IEC 81001-5-1 has emerged as the global benchmark for securing health software, demanding strong risk management, secure-by-design practices, and continuous monitoring throughout the software lifecycle.
Cyberintelsys , a leading Medical Device & Health Software Cybersecurity Company, helps manufacturers, hospitals, and digital health providers in New Zealand achieve full IEC 81001-5-1 cybersecurity readiness. With deep expertise in medical software security, threat modelling, and regulatory compliance, Cyberintelsys delivers end-to-end Risk Assessments, Vulnerability Testing, Documentation Support, and Compliance Roadmaps to ensure your products meet global safety and security standards.
Whether you’re preparing for global market approvals, securing SaaS-based clinical applications, or strengthening your medical device software ecosystem, Cyberintelsys provides the trusted expertise to help you achieve secure, compliant, and future-ready health software.
What Is IEC 81001-5-1 – The Global Standard for Health Software Cybersecurity
IEC 81001-5-1 is the world’s first cybersecurity standard tailored specifically for:
- Health software
- Health IT systems
- Connected medical applications
- Digital health platforms
- Clinical decision support tools
It defines the essential requirements for secure software development, risk management, vulnerability handling, and lifecycle cybersecurity.
Why New Zealand Healthcare Organizations Need IEC 81001-5-1 Compliance
Cyberattacks on healthcare systems are increasing globally and New Zealand has experienced multiple incidents affecting hospitals, patient data, and medical operations.
IEC 81001-5-1 helps healthcare providers:
- Protect electronic patient data (EHR/EMR)
- Secure telehealth & mobile health applications
- Reduce healthcare ransomware risks
- Strengthen health IT infrastructure security
- Demonstrate regulatory & market compliance
- Build trust with hospitals, vendors & authorities
Cyberintelsys IEC 81001-5-1 Cybersecurity Assessment Methodology
Cyberintelsys offers a rigorous, multi-layered assessment aligned with international cybersecurity and healthcare standards.
1. Software Architecture & Health IT System Review
- Cloud infrastructure assessment
- API & backend security analysis
- Mobile app security evaluation
- IoMT & medical device integration review
- Data flow mapping & security posture scoring
2. Secure Software Development Lifecycle (SSDLC) Assessment
We evaluate the entire development lifecycle:
- Secure design & threat modeling
- Source code review
- Vulnerability management
- CI/CD pipeline security
- Patch & update governance
3. Cyber Risk Assessment & Threat Modeling
Cyberintelsys applies healthcare-specific threat frameworks such as:
- CREST
- OWASP
- MITRE ATT&CK for Healthcare
- FDA cybersecurity guidance
This identifies vulnerabilities that may impact patient safety, clinical workflows, or data integrity.
4. Vulnerability Assessment & Penetration Testing (VA/PT)
Our health software VA/PT includes:
- Web & mobile app penetration testing
- Cloud security testing
- API vulnerability scanning
- Authentication & authorization testing
- Encryption & data protection assessment
5. IEC 81001-5-1 Compliance Readiness Documentation
We help you prepare all required documentation:
- Cyber risk management file
- SSDLC process documentation
- Vulnerability handling procedures
- Security architecture evidence
- Compliance mapping matrix
- Policies & security controls
Benefits of Partnering With Cyberintelsys
Cyberintelsys provides unmatched expertise in healthcare cybersecurity and medical software compliance.
Why organizations choose us:
- Global experience with health software security
- Deep understanding of New Zealand healthcare regulations
- End-to-end IEC 81001-5-1 compliance support
- Expert VA/PT for EHR, cloud apps, IoMT & medical software
- Faster certification and market approval
- Strengthened cybersecurity maturity
Industries & Platforms We Support
- Hospitals & healthcare systems
- Health software developers
- Telehealth & mHealth platforms
- IoMT & connected medical devices
- Clinical decision support software
- Health analytics platforms
- Cloud-based healthcare SaaS
Conclusion
As cyber threats evolve, IEC 81001-5-1 compliance is crucial for safeguarding New Zealand’s healthcare systems. From health software developers to hospitals and medical SaaS providers, every organization handling health data must ensure strong cybersecurity resilience.
With Cyberintelsys as your cybersecurity partner, you receive:
- Comprehensive IEC 81001-5-1 assessments
- Advanced medical software security testing
- Expert documentation & compliance support
- Stronger cybersecurity maturity across the software lifecycle
Cyberintelsys — New Zealand’s trusted partner for healthcare cybersecurity, health software risk assessment, and IEC 81001-5-1 compliance readiness.
