current language
Japan available in the following languages:
or select your TÜV Rheinland region / country website:

Cyber Security for Medical Devices and Systems

Cyber security testing for safe medical devices and medical systems | TÜV Rheinland

Safe and secure medical devices with recognized cyber security testing

We provide the required expertise to identify and understand cyber security issues regarding medical devices and systems | TÜV Rheinland

Many modern medical devices including implantable and wearable mechanisms that are used both in professional health care facilities as well as at home rely on cutting-edge technologies. Although these new developments can deliver more convenient care, they rely on state-of-the art components and networked systems to function efficiently, communicate effectively, diagnose problems precisely and respond safely.

In efforts to provide the best possible care in a cost-efficient and patient-friendly way, hospitals and care-givers depend on more pieces of networked equipment to share data, report results, analyze individual situations and provide the appropriate medical treatment based on reliable and secure information. Although older devices developed prior to cybersecurity requirements are of particular concern, any medical device that runs on software using either a wireless or wired connection can be vulnerable to cyber threats that can access personal data or, in the worst case, place seriously ill patients in grave danger.

Whether developing new devices in an R&D group, certifying quality assurance, producing medical devices according to specifications, or working as part of a product security incident response team (PSIRT), we help you recognize vulnerabilities and provide you solutions strengthening the reputation of your medical products to win customer trust and expand your market share.

Prove the high quality and regulatory compliance of your medical devices with our recognized testing and analysis for effective cybersecurity!

Confident patients and partners with proven cyber security for your medical devices

We provide you the expertise you need to identify and understand the cyber security issues facing your device based on its design and purpose. Our experienced team of international specialists is on call at any time, anywhere in the world to testing your particular device. We conduct comprehensive threat analysis and risk assessment (TARA) as well as provide you recommendations of effective strategies and solutions to ensure the safe and secure use of your medical devices according to applicable regulatory standards to reduce your corporate liability and boost confidence in your products and services.

MDR/745/2017, a new EU Medical Device Regulation, explicitly addresses cybersecurity requirements. In addition, the MDCG (Medical Device Coordination Group), which is composed of representatives from EU member states, has issued a guidance document focusing on cyber security. As a result of those regulatory requirements medical device manufacturers must implement appropriate measures from the design and development stages to ensure the cybersecurity of medical devices

Comprehensive cyber security testing, analysis and remediation

Our comprehensive services aimed at ensuring your medical devices the best possible cyber security against hacks and other cyber crime are broken into three areas:

  • Cyber security testing
    • Penetration test – Current hacker methods are used to attempt to penetrate the system. Testing is conducted to identify software defects, dangerous settings and other vulnerabilities.
    • Fuzz test – Testing to identify security problems are performed to uncover software defects, bugs, and other areas of susceptibility. Data and network traffic is observed to ensure the correct flow of information intended for the device.
    • Vulnerability scanning – Analysis of the software and hardware used for system construction according to the National Vulnerability Database (NVD). Analysis takes both the web and network application levels into consideration.
    • Application source code review – Compilation and review of source code to check for possible security risks or the use of deprecated programming techniques.

  • Threat analysis and risk assessment (TARA) – This engineering methodology is used to identify and assess cyber vulnerabilities and determine countermeasures focused on eliminating those shortcomings.
  • Remediation recommendations – Effective solutions are suggested to ensure the highest level of cyber security and compliance to any applicable standards.

Your trusted partner for cyber security

Our cyber security testing services are uniquely designed to expose, analyze and solve any vulnerability issues affecting your medical device. We are your recognized and trusted partner who understands challenges to the industry as well as the environments in which your products are used due to our many years of work for the medical industry. Our experts are extensively trained and experienced in applying the TARA methodology to ensure a comprehensive examination of any medical device and its networked support systems. We understand the critical importance of secure medical devices and work to help you demonstrate the high quality and robust security characteristics of your medical products.

Tap into our expertise to ensure your medical devices are protected against cyber attack!

This might also interest you

EU Medical Device Regulation MDR 2017/745

EU Medical Device Regulation MDR 2017/745

Supporting access to European markets for medical devices under MDR 2017/745.


Non-Active Medical Device Testing

Guarantee the quality of your non-active medical devices with a GM test mark | TÜV Rheinland

Increase your competitive edge and certify your non-active medical device products.



Get in contact with us!

Get in contact with us!

Last Visited Service Pages