Medical Device Cybersecurity Audit Checklist

A comprehensive checklist for auditing cybersecurity processes in medical device development and maintenance, ensuring compliance with ISO 13485 and relevant cybersecurity standards, and improving overall device security and patient data protection.

Medical Device Cybersecurity Audit Checklist
by: audit-now
4.7

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About This Checklist

The Medical Device Cybersecurity Audit Checklist is a crucial tool for healthcare organizations to ensure compliance with ISO 13485 and relevant cybersecurity standards in the development and maintenance of connected medical devices. This comprehensive checklist addresses critical aspects of cybersecurity risk management, threat modeling, secure software development, and ongoing security monitoring for medical devices. By implementing robust cybersecurity practices, manufacturers can protect patient data, maintain device integrity, and safeguard against potential cyber threats. This checklist aids in systematically evaluating security controls, vulnerability management, incident response procedures, and secure communication protocols, ultimately contributing to the development of more resilient and trustworthy medical devices in the increasingly connected healthcare ecosystem.

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Industry

Healthcare

Standard

ISO 13485, IEC 80001, NIST Cybersecurity Framework

Workspaces

Medical Device Software Development and Testing Facility

Occupations

Cybersecurity Specialist
Software Engineer
Network Security Expert
Quality Assurance Manager
Regulatory Affairs Specialist

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