PENETRATION TESTING FOR MEDICAL DEVICES

Secure Your Medical Device
Achieve Regulatory Compliance

Specialized penetration testing for medical devices (MDR), SaMD, and DiGAs. We help you meet MDR cybersecurity requirements.

Focus on Medical Device Regulation (MDR)

Our penetration tests are specifically designed to meet the stringent cybersecurity requirements of the Medical Device Regulation (MDR). We help you identify and mitigate risks, ensuring the safety and security of your medical devices and patient data.

Compliance Standards We Address

Our penetration tests help you meet the cybersecurity requirements of major medical device regulations and standards.

MDR (EU 2017/745)

Annex I cybersecurity requirements for CE marking in Europe

BSI TR-03161

German technical guideline for mobile health applications (DiGA)

IEC 62304

Medical device software lifecycle processes

ISO 14971

Risk management for medical devices including cybersecurity risks

MDCG 2019-16

EU guidance on cybersecurity for medical devices

Our Medical Device Penetration Testing Services

We provide comprehensive testing services to ensure your medical devices are secure and compliant.

SaMD & DiGA Penetration Testing

Specialized security assessments for Software as a Medical Device (SaMD) and Digital Health Applications (DiGAs) to ensure patient safety and regulatory compliance.

AI/LLM Security for Medical Applications

Cutting-edge security testing for AI and Large Language Models in healthcare, addressing unique risks like model manipulation and data privacy.

Medical Device Penetration Testing

We test the security of your connected medical devices to identify and remediate vulnerabilities before they can be exploited.

Mobile & Web Application Pentesting for Healthcare

We secure the mobile and web applications that control or connect to your medical devices and handle patient data.

Cloud Security for Medical Devices

We review your cloud configurations (AWS, Azure, GCP) for security best practices to protect sensitive patient data (ePHI).

Regulatory Compliance Support

We help you navigate the complex cybersecurity requirements of the MDR, FDA, and other international standards.

What We Test

Our comprehensive penetration tests cover all aspects of your medical device ecosystem.

Device & Software Security

Mobile apps, desktop applications, embedded software, firmware, and secure update mechanisms

Application Security

Mobile apps, web interfaces, desktop software, and APIs that interact with your device

Network Security

Bluetooth, Wi-Fi, cellular, and other connectivity protocols used by your device

Data Security

Encryption, data storage, transmission security, and patient data protection

Authentication & Access Control

User authentication, role-based access, session management, and privilege escalation

Hospital/MedTech-Specific Protocols

HL7v2, v3 and FHIR; DICOM and other medical communication protocols including their implementation and security

Third-Party Components

Libraries, frameworks, and external services integrated into your solution

Common Medical Device Vulnerabilities

Based on our experience testing medical devices, these are the most critical security issues we frequently identify.

Weak Authentication

Default credentials, hardcoded passwords, or weak authentication mechanisms that could allow unauthorized access

Unencrypted Communications

Patient data transmitted without encryption over Bluetooth, Wi-Fi, or internet connections

Insecure Update Mechanisms

Firmware updates without signature verification, allowing malicious code injection

Insufficient Input Validation

Lack of proper validation leading to injection attacks or buffer overflows

Insecure API Endpoints

Unprotected or poorly secured APIs that could expose sensitive patient data or allow unauthorized system access

Privacy Violations

Excessive data collection, insecure data storage, or improper data retention

Our Approach to Medical Device Security

We follow a risk-based approach to medical device penetration testing, focusing on the areas that pose the greatest risk to patient safety and data security.

1

Threat Modeling & Risk Analysis

We identify potential threats and vulnerabilities in your medical device ecosystem.

2

Penetration Testing & Vulnerability Exploitation

We simulate real-world attacks to identify and exploit vulnerabilities in your medical devices.

3

Reporting & Remediation Support

We provide a detailed report with actionable recommendations and support your team in securing your medical devices and closing security gaps.

4

Regulatory Compliance Documentation

We provide the documentation you need to demonstrate your compliance with MDR and FDA cybersecurity requirements.

Testing Timeline

Typical project duration based on device complexity.

1

Initial Contact & Requirements Analysis

1 day

Initial discussion to understand your requirements and project goals

2

Scoping & Proposal

1-2 days

Detailed alignment of test scope and creation of a tailored proposal

3

Project Kickoff

1 day

Obtain necessary information and files, set up test environment, and final alignment

4

Testing Execution

5-15 days

Active penetration testing based on device complexity and scope

5

Report Generation

2-3 days

Comprehensive documentation of findings and remediation guidance

6

Remediation Support

As needed

Support your team in fixing identified vulnerabilities

7

Retest & Verification

1-2 days

Verify that vulnerabilities have been properly fixed and create a remediation report

Why Trust Machine Spirits with Your Medical Device Security?

Deep Expertise in Medical Device Security

Our team has extensive experience in medical device security and a deep understanding of the regulatory landscape.

Focus on Patient Safety

We prioritize patient safety in everything we do, ensuring that your medical devices are secure and reliable.

Actionable & Compliant Reporting

Our reports are designed to meet the needs of both your technical team and regulatory bodies.

Frequently Asked Questions

When should we conduct penetration testing?

Ideally, penetration testing should be performed during development (shift-left approach) and before regulatory submission. Regular testing is also recommended for post-market surveillance.

What's the difference between vulnerability scanning and penetration testing?

Vulnerability scanning uses automated tools to identify known vulnerabilities. Penetration testing involves manual testing by security experts who attempt to exploit vulnerabilities and chain attacks, providing deeper insights into real-world risks.

How do you ensure patient safety during testing?

We always conduct tests in isolated environments using test devices. We never test on production systems or devices actively used for patient care. Our methodology prioritizes safety and follows medical device testing best practices.

What deliverables do we receive?

You receive a detailed technical report with vulnerability descriptions, proof-of-concept code, risk ratings, and specific remediation guidance. We also provide an executive summary and support for regulatory submissions.

Can you help with regulatory submissions?

Yes, our reports are designed to support regulatory submissions. We provide documentation that demonstrates compliance with cybersecurity requirements for MDR and other EU regulations.

Clear, Actionable, and Compliant Reporting

Our reports provide a clear and concise overview of our findings, with actionable recommendations that are easy to understand and implement. We also provide the documentation you need to demonstrate your compliance with regulatory requirements.

Ready to Secure Your Medical Device?

Contact us today and learn how we can help you secure your medical devices and achieve regulatory compliance.

Schedule Your Consultation