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IEC 81001
Compliance Services
At Cyberintelsys Consulting Services, we help healthcare technology providers achieve compliance with IEC 81001-5-1 the globally recognized standard for securing health software and IT systems throughout their lifecycle.
Our services cover the full IEC 81001-5-1 lifecycle from gap assessments and risk management to secure software integration, monitoring and certification readiness ensuring healthcare systems are safe, resilient and compliant.
IEC 81001-5-1 provides a framework for securing health software and IT systems in healthcare environments. It emphasizes risk-based, lifecycle-oriented cybersecurity practices to protect patient safety, clinical continuity and sensitive health data.
Our services help healthcare organizations embed these principles to build secure, compliant and resilient systems.
To help organizations implement IEC 81001-5-1 efficiently, embedding cybersecurity into health software and IT systems from design to deployment reducing regulatory risk, enhancing patient safety and enabling continuous compliance.
Faster Compliance Readiness
Accelerate IEC 81001-5-1 implementation with structured gap assessments, risk evaluation and remediation planning.
Integrated Security by Design
Embed cybersecurity into all phases of software development, testing and operations.
Documentation & Proof
Maintain audit-ready records, risk assessments and compliance evidence across the software lifecycle.
Reduced Regulatory Risk
Ensure alignment with IEC 81001-5-1, FDA, EU MDR and other healthcare cybersecurity requirements.
Trusted Certification
Be fully prepared for audits and regulatory reviews with guidance from experienced professionals.
Cybersecurity Gap Assessment
Evaluate current health software and IT processes against IEC 81001-5-1 requirements.
Risk Management & Governance Support
Develop risk frameworks, policies and mitigation strategies aligned with IEC 81001-5-1.
Secure Development Lifecycle Integration
Embed threat modeling, secure coding and verification into software lifecycle processes.
Verification & Validation
Conduct penetration testing, security audits and compliance reviews to ensure alignment with standards.
Lifecycle Monitoring & Maintenance
Provide ongoing patch management, vulnerability monitoring and change control.
Advisory Services
Step-by-step guidance for secure software integration, documentation and audit readiness.
Compliance as a Service
01
Secure Development Support
Continuous guidance on secure coding, threat modeling and SDLC integration.
02
Risk & Safety Monitoring
Ongoing assessment of software risks, vulnerabilities and cybersecurity controls.
03
Documentation & Evidence Maintenance
Maintain audit-ready records, risk assessments and compliance documentation.
04
Regulatory Advisory
Stay updated on IEC 81001-5-1 revisions, FDA and EU MDR cybersecurity expectations.
05
Incident Response & Threat Management
Support proactive detection, vulnerability remediation and incident response planning.
06
Audit & Certification Support
Assist with regulatory audits, certification readiness and evidence submission.
Our Engagement Approach
Risk Management Framework
Implement risk assessment, mitigation and traceability practices.
Secure Development Integration
Embed security practices, threat modeling and verification processes into SDLC.
Gap Assessment
Evaluate software and IT systems for alignment with IEC 81001-5-1 domains.
Certification Readiness & Support
Prepare for regulatory audits, address findings and ensure sustained compliance
Lifecycle Monitoring & Advisory
Continuous oversight of risk, patching and change management.
Verification & Validation
Conduct audits, penetration testing and compliance reviews for assurance.
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Certified Healthcare Cybersecurity Experts
Professionals with hands-on experience in IEC 81001-5-1, ISO 14971 and healthcare cybersecurity standards.
Comprehensive End-to-End Support
From gap assessment and risk management to secure SDLC integration and certification readiness.
Standards-Aligned Methodology
Implementation aligned with IEC 81001-5-1 and global regulatory requirements.
Tailored Documentation & Controls
Custom compliance strategies, technical records and verification procedures for each healthcare system.
Continuous Compliance Maintenance
Ongoing monitoring, advisory and risk management for long term IEC 81001-5-1 alignment.
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Frequently Asked Questions
Quick Answers to Your Cyber Security Concerns
IEC 81001-5-1 defines cybersecurity requirements for health software and IT systems throughout the lifecycle.
Depending on system complexity, it typically takes 1–3 months for full compliance and certification readiness.
Yes. We guide SDLC integration, threat modeling, secure coding and verification.
Absolutely. We maintain risk records, compliance evidence and technical documentation.
Yes. Our Compliance as a Service (CaaS) ensures ongoing monitoring, documentation maintenance and advisory for continuous regulatory alignment.