Medical Device & Healthcare Cybersecurity
Comprehensive cybersecurity solutions for medical device manufacturers, laboratories, and healthcare providers. Ensure compliance with MDR 2017/745, IVDR 2017/746, and European cybersecurity regulations while protecting patient safety and data integrity.
Key Stakeholders in Medical Device & Healthcare Cybersecurity
We provide tailored cybersecurity services for each stakeholder in the medical device ecosystem
Medical Device OEMs
Original Equipment Manufacturers face complex regulatory requirements and need comprehensive security throughout the product lifecycle.
- Secure Product Development Framework (SPDF) Implementation
- Software Bill of Materials (SBOM) Management
- Pre-market Cybersecurity Documentation
- Threat Modeling & Risk Assessment
- Vulnerability Management Programs
- Post-market Surveillance Systems
- FDA & CE Mark Compliance Support
Hospitals & Healthcare Providers
Healthcare delivery organizations need to protect patient data and ensure continuous operation of critical medical systems.
- Medical Device Security Program Development
- Network Segmentation & Zero Trust Architecture
- Incident Response Planning & SOC Services
- Clinical System Security Assessments
- Staff Security Awareness Training
- Business Continuity & Disaster Recovery
- Third-party Vendor Risk Management
Laboratories & Diagnostic Centers
Clinical laboratories require specialized security for diagnostic equipment and sensitive test data.
- Laboratory Information System (LIS) Security
- Diagnostic Equipment Hardening
- Data Encryption & Access Control
- Secure Integration with Hospital Networks
- Compliance with ISO 15189 Security Requirements
- Audit Trail & Activity Monitoring
- Backup & Recovery Solutions
Medical Software Developers
SaMD and healthcare software developers need to integrate security throughout the development lifecycle.
- Secure SDLC Implementation
- IEC 62304 Compliance Support
- Security Architecture Design
- Code Security Reviews & Testing
- Cloud Security for Healthcare Apps
- API Security & Integration Testing
- Mobile Health App Security
Healthcare IT Integrators
System integrators need to ensure secure deployment and integration of medical devices and healthcare IT systems.
- Secure Integration Architecture
- Interoperability Security Testing
- Network Security Design
- Security Configuration Management
- Integration Risk Assessments
- Security Monitoring Solutions
- Compliance Validation Services
Regulatory & Certification Bodies
Support for regulatory compliance and certification processes with comprehensive documentation and assessment.
- Technical Documentation Review
- Cybersecurity Assessment Protocols
- Compliance Gap Analysis
- Audit Preparation & Support
- Standards Interpretation Guidance
- Risk Management Documentation
- Certification Process Support
Medical Device Cybersecurity Regulations
🇪🇺 MDR 2017/745 – Medical Device Regulation
Scope: All medical devices placed on the EU market
Key Requirements:
- General Safety and Performance Requirements (GSPRs) in Annex I
- Software validation and cybersecurity risk management
- Post-market surveillance obligations
- Technical documentation requirements
Our Support: Complete MDR cybersecurity compliance program including risk assessment, technical file preparation, and post-market surveillance systems.
🇪🇺 IVDR 2017/746 – In Vitro Diagnostic Regulation
Scope: All in vitro diagnostic medical devices
Key Requirements:
- Security requirements for diagnostic software
- Data integrity and patient data protection
- Full QMS compliance by May 26, 2025
- Risk-based classification approach
Our Support: IVDR-specific cybersecurity assessments, QMS implementation, and certification support.
🇺🇸 FDA PATCH Act & Section 524B
Scope: Cyber devices marketed in the United States
Key Requirements:
- Secure Product Development Framework (SPDF)
- Software Bill of Materials (SBOM)
- Vulnerability management plans
- Post-market cybersecurity management
Our Support: FDA submission preparation, SBOM creation, and lifecycle security planning.
🇪🇺 NIS2 Directive
Scope: Essential and important entities in healthcare
Key Requirements:
- Risk management measures
- Incident reporting within 24 hours
- Business continuity planning
- Supply chain security
Our Support: NIS2 compliance assessment, incident response procedures, and security governance.
🇪🇺 GDPR – Data Protection
Scope: Processing of patient health data
Key Requirements:
- Privacy by design and default
- Data protection impact assessments
- Breach notification procedures
- Patient rights management
Our Support: GDPR compliance for medical devices, privacy engineering, and data governance.
🇪🇺 EU AI Act
Scope: AI-enabled medical devices and systems
Key Requirements:
- Risk categorization of AI systems
- Transparency and explainability
- Human oversight mechanisms
- Full compliance by August 2026
Our Support: AI risk assessment, compliance roadmap, and technical documentation.
Medical Device Cybersecurity Standards & Frameworks
IEC 62304
Medical device software lifecycle processes
ISO 14971
Risk management for medical devices
IEC 81001-5-1
Security for healthcare delivery organizations
IEC 60601-4-5
Medical electrical equipment security
NIST CSF 2.0
Cybersecurity Framework for healthcare
AAMI TIR57
Medical device security risk management
ISO 27001/27002
Information security management
IEC 62443
Industrial control system security
Our Comprehensive Services
End-to-End Medical Device Cybersecurity Solutions
Security Assessment & Testing
Comprehensive vulnerability assessments, penetration testing, and security architecture reviews specifically designed for medical devices and healthcare systems.
Regulatory Compliance
Expert guidance on MDR, IVDR, FDA, and other global regulations. We prepare all necessary documentation and support you through the certification process.
Training & Awareness
Specialized training programs for medical device manufacturers, healthcare staff, and IT teams on cybersecurity best practices and regulatory requirements.
Incident Response
24/7 incident response services with specialized expertise in medical device and healthcare environments. Minimize downtime and protect patient safety.
Lifecycle Management
Continuous security monitoring, vulnerability management, and post-market surveillance throughout the entire product lifecycle.
Secure Architecture Design
Design secure-by-default architectures for medical devices, healthcare networks, and clinical systems that meet regulatory requirements.
Ready to Secure Your Medical Devices and Healthcare Systems?
With evolving regulations and increasing cyber threats, now is the time to strengthen your cybersecurity posture. Our experts are ready to help you navigate the complex landscape of medical device cybersecurity.
Get Expert ConsultationWhy Choose Secberg for Medical Device Cybersecurity?
🏆 Industry Expertise
Deep understanding of medical device regulations including MDR 2017/745, IVDR 2017/746, FDA requirements, and European cybersecurity directives.
🌍 Global Compliance
Support for multi-regional compliance strategies, helping you meet requirements in EU, US, and other major markets simultaneously.
💡 Practical Solutions
Risk-based approach that balances security requirements with clinical functionality and patient safety considerations.