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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
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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

Medical Device Standards and Cybersecurity

Workspaces

Medical Device Manufacturing Facilities

Occupations

Cybersecurity Specialist
Software Engineer
Network Security Expert
Quality Assurance Manager
Regulatory Affairs Specialist
1
Is the medical device software compliant with ISO 13485 and IEC 80001 standards?
2
What is the date of the last vulnerability assessment conducted?
3
How many vulnerabilities were identified in the latest assessment?
Min: 0
Target: 0
Max: 100
4
Is the patch management process for the device up-to-date?
5
Please provide insights or findings from the latest threat modeling exercise.
6
Is the data protection strategy compliant with NIST Cybersecurity Framework?
7
Is there an incident response plan in place for the medical device software?
8
When was the last review of any cybersecurity incidents conducted?
9
How often is incident response training conducted for staff?
Min: 0
Target: 1
Max: 12
10
Was a post-incident analysis completed for the last recorded incident?
11
What improvements have been identified for incident handling processes?
12
Is the incident reporting process compliant with regulatory requirements?
13
How often is a comprehensive risk assessment performed on medical device software?
14
When was the last risk assessment conducted?
15
How many high-risk vulnerabilities were identified in the latest risk assessment?
Min: 0
Target: 0
Max: 50
16
Is there an active risk mitigation plan for identified cybersecurity risks?
17
What improvements have been identified for the risk management process?
18
Is the risk management process compliant with relevant cybersecurity standards?
19
Is there a cybersecurity training program available for all medical device software personnel?
20
When was the last cybersecurity training session conducted?
21
What percentage of personnel have completed the cybersecurity training?
Min: 0
Target: 100
Max: 100
22
What were the results of the last phishing simulation exercise conducted?
23
What feedback have participants provided about the cybersecurity training program?
24
Is the training program compliant with industry regulations and standards?
25
Is there a formal mechanism for reporting cybersecurity incidents?
26
When was the last cybersecurity incident reported?
27
What is the average response time to cybersecurity incidents?
Min: 0
Target: 30
Max: 120
28
What is the resolution status of the most recent cybersecurity incident?
29
What lessons were learned from the last cybersecurity incident?
30
Is the incident management process compliant with internal policies and external regulations?

FAQs

The checklist covers areas such as threat modeling, secure software development practices, encryption implementation, access control mechanisms, network security, vulnerability management, security testing, incident response planning, and ongoing security monitoring and updates.

It includes specific items to verify that potential cybersecurity risks are identified and mitigated throughout the device lifecycle, from design and development to post-market support and updates.

The audit should involve cybersecurity specialists, software engineers, network security experts, quality assurance personnel, and regulatory affairs professionals to ensure a comprehensive evaluation of security aspects.

Cybersecurity audits should be performed at key stages of product development, before major software updates, and at least annually for marketed devices to ensure ongoing protection against evolving cyber threats.

Inadequate cybersecurity can lead to data breaches, compromised device functionality, patient harm, loss of trust, regulatory non-compliance, and significant financial and reputational damage for the manufacturer.

Benefits of Medical Device Cybersecurity Audit Checklist

Ensures compliance with ISO 13485 and cybersecurity standards for medical devices

Reduces the risk of cyber attacks and unauthorized access to medical devices

Enhances patient data protection and privacy

Improves overall device reliability and trustworthiness

Facilitates regulatory approvals by demonstrating comprehensive cybersecurity measures