Medical device cyber security testing and assessment services

Why is the cyber security of medical devices important?

There are regulatory, ethical and financial reasons to ensure the cyber security of medical devices and their accessories. For example:

Regulatory requirements have to be met before medical products can be launched in different markets. This includes both European regulatory requirements such as the in vitro diagnostic regulation (IVDR), the medical device regulation (MDR), the in vitro diagnostic directive (IVDD), the medical devices directive (MDD) and the active implantable medical devices directive (AIMDD), as well as non-European regulatory requirements set by the United States Food and Drugs Administration (FDA), the Chinese National Medical Products Administration (NMPA), the Canadian Health Ministry (Health Canada) and the Japanese Ministry of Health, Labour and Welfare (MHLW).

If unauthorised access is gained to a medical device, there can be severe consequences. That is why it's crucial for cyber security risks to be considered both during both the development phase as in the procurement and installation of medical devices.
Patient privacy within the framework of the doctor-patient relationship is extremely important and could be compromised in a data breach.

Device manufacturers and health organisations that use unsecure technology and fail to guarantee the cyber security of their medical devices pay heavy penalties, both financially and in terms of their reputation.

Our services to test and assess the cyber security of medical devices

Globally, there is an increasing awareness of cyber security for medical devices from the regulatory organisations. For example, the FDA, the European Commission and Health Canada have published guidelines on how to meet cyber security regulations. These guidelines specify whether it is necessary to carry out vulnerability scans or penetration tests during the development of medical devices. It is better to implement the cyber security requirements early in the development process rather than having to include and integrate these requirements to the finished product.

We answer some of the most frequently asked questions to keep you up to date with the latest developments.

Our testing labs offer a comprehensive range of services to test and assess the cyber security of your medical devices. These include:

Cybersecurity Trainings
Trainings are provided to bring awareness and understanding of cybersecurity in medical devices. The objective of the training is to understand requirements defined in regulatory frameworks such as:
- European requirements such as MDCG 2019-16
- US FDA requirements such as
  - FDA QSR
  - Pre-Market Management of Cybersecurity
  - Post-Market Management of Cybersecurity
  - Cybersecurity for networked medical devices
- Chinese NMPA
- On Demand trainings for local frameworks such as Japanese, Singaporean, Brazil and Korean
Furthermore, trainings can be provided to understand the implementation of Cybersecurity in medical devices according to international standards such as:
- IEC TR 60601-4-5 Medical device Cybersecurity
- ISO 14971:2019 Medical device Risk Management
- ISO 62443-3-2 Security for industrial automation
Concept evaluations
The concept evaluations aim to identify cybersecurity GAPs by assessing against international/harmonized standards, cybersecurity state-of-the art and regulatory requirements such as:
- IEC TR 60601-4-5 Medical device Cybersecurity
- IEC 81001-5-1 Security - Activities in the product life cycle
- ISO 62443-3-2 Security for industrial automation
- MDCG 2019-16 Medical device cybersecurity
- Pre-Market Management of Cybersecurity
- Post-Market Management of Cybersecurity
- Cybersecurity for networked medical devices
Vulnerability Scans / Assessment and Static / dynamic code analysis
The objective of vulnerability scans is to identify and detect known weaknesses in computers, networks or applications (programs). The aim is to perform remediation activities once critical vulnerabilities are identified by the manufacturer. The benefit of this approach is to close Vulnerability Gaps and maintain strong security in medical devices

The services include:
- Vulnerability scans (e.g., Network scanning, Web-Application Scanning, Firmware/software scanning) with documentation and grading of the identified vulnerabilities in a vulnerability assessment report.
- Static and dynamic code analysis including a dedicated test report with grading of the vulnerabilities
Penetration Tests and fuzz testing
The objective of a penetration test is to simulate a cyber attack to evaluate the security status of the medical device/software. The aim is to identify unknown weaknesses found during manual tests. Test report results can be used as an objective evidence for the effectiveness of cybersecurity in a medical device (similar to a 60601-1 report being used as an objective evidence for the safety of a medical device).

The services include:
- Penetration tests at TÜV Süd are performed according to the best practice from all major frameworks (such as OSSTM, PTES, NIST 800-115, ISSAF and OWSAP)
- Penetration testing and fuzz testing are performed under DAkkS accreditation for medical device cybersecurity according to IEC/TR 60601-4-5 considering the basic safety and essential performance of a medical device.
- Identification of extra testing requirements not covered by the standards listed above
- Development of product-specific testing methods
- Assessment of provider-specific security solutions

Medical device cyber security

Why is the cyber security of medical devices important?

Our services to test and assess the cyber security of medical devices

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