Regulatory Considerations for Establishing a Process for Cybersecurity for Medical Devices

Medical devices have traditionally focused on functionality and efficacy, but the recent integration of connectivity features has introduced a new dimension of vulnerability. These devices now communicate through networks, storing and transmitting sensitive patient data, making them susceptible to cyber threats. Software vulnerabilities can be exploited to gain unauthorized access, manipulate device functionality, or steal patient information. Such breaches not only compromise patient privacy but also pose significant risks to their health and safety. Therefore, nowadays, cybersecurity considerations should be as much a part of device development as usability requirements or risk management.

This blog post explores the considerations device manufacturers should take into account when establishing a process for cybersecurity for medical devices.

Navigating the Compliance Landscape for Cybersecurity for Medical Devices

Recognizing the critical importance of cybersecurity in healthcare, regulatory bodies worldwide are starting to impose stringent requirements on medical device manufacturers.

These cybersecurity requirements define the security measures expected to be applied throughout the total product lifecycle (TPLC) of devices, ensuring they are securely designed and capable of mitigating emerging risks. This can be achieved through implementing a Secure Product Development Framework (SPDF) based on IEC 81001-5-1 and principles outlined in MDCG 2019-16. Additionally, recommendations of the following FDA guidances can be taken into account:

•       FDA-2021-D-1158: FDA Guidance on Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Sep. 2023)

•       FDA-2015-D-5105: FDA Guidance on the Post-Market Management of Cybersecurity in Medical Devices (Dec. 2016)

Key Considerations in Cybersecurity for Medical Devices 

In setting up a process for cybersecurity for medical devices, it's imperative to align with the company's security policy, aiming to design and manufacture trustworthy and resilient cyber devices. These objectives, documented in the Total Product Lifecycle (TPLC) Security Management Plan, encompass authenticity, authorization, availability, confidentiality, and secure updatability.


While setting up a robust cybersecurity process, several key aspects and plans must be defined, as summarized below:


Secure Design Principles: Integrating security measures into the design phase is crucial for building resilient medical devices. Implementing encryption protocols, access controls, and secure authentication mechanisms can prevent unauthorized access and data breaches.


Threat modeling: A proactive approach to identify and mitigate cybersecurity risks in software and system design, threat modeling involves systematically analyzing potential threats, vulnerabilities, and attack vectors that could compromise the security of a system. By understanding potential threats early in the development process, organizations can implement appropriate security controls and countermeasures to mitigate risks effectively. Threat modeling helps prioritize security efforts, improve decision-making, and strengthen the overall security posture of software and systems that are part of their medical devices.


Software Bill of Materials (SBOM): A comprehensive inventory that provides detailed information about all software components used in a particular product or system, the SBOM is essential for understanding software composition and identifying potential security vulnerabilities and licensing issues. SBOMs enable organizations to track and manage software assets effectively, facilitating risk assessment, vulnerability management, and compliance efforts. Additionally, SBOMs enhance transparency and accountability in the software supply chain, enabling stakeholders to make informed decisions about software procurement, integration, and maintenance.


Deployment Strategy: Secure software deployment is imperative in cybersecurity for medical devices. It involves employing encryption, access controls, and secure coding practices to safeguard against threats.


Software Updates and Patch Management Strategy: Regular software updates and patch management are essential for addressing known vulnerabilities and enhancing device security. Manufacturers should establish procedures for the timely deployment of patches and updates to mitigate emerging threats.


SOUP / OTS Contingency Planning: Planning for contingencies for third-party SOUP / OTS components includes strategies for updating or replacing them if support ends or other issues arise, ensuring continuity and security in software systems.


Vulnerability Identification Plan: It is paramount to outline how vulnerabilities and exploits will be monitored and identified to address cybersecurity risks. Additionally, it is in the manufacturer’s best interest to establish a process for disclosing vulnerabilities to users, including a description, severity score, affected product versions, and resolution details.


Continuous Monitoring and Incident Response: Establishing mechanisms for continuous monitoring enables early detection of security incidents and anomalous behavior. Manufacturers should develop comprehensive incident response plans to effectively mitigate threats and minimize the impact of security breaches.


Recovery Plan / Process: Creating a recovery plan or process involves strategizing for restoring compromised capabilities, services, or data in the aftermath of a cybersecurity incident. This ensures swift and effective response to minimize disruptions and safeguard against potential losses.


Restoration Process: Planning for restoring capabilities, services, or data to their previous or acceptable operational state after a cybersecurity event.


Periodic Security Testing and Monitoring: Security Testing must be performed at regular intervals (at least once a year) commensurate with the risk of the device to monitor the effectiveness of risk controls and to identify new vulnerabilities. Continuous monitoring of complaints, IT systems and assets, public databases, as well as SOUP/ OTS components provides an additional level of assurance and allows the timely identification of potential cybersecurity threats.


Decommissioning Process: The decommissioning process entails implementing protocols to securely retire devices, including thorough sanitization of sensitive data and software. This safeguards against potential breaches, ensuring confidentiality and protecting proprietary information from unauthorized access or misuse.


These plans collectively ensure proactive measures are in place to mitigate cybersecurity risks and respond effectively to any incidents, safeguarding both the integrity of the medical devices and the privacy of users' data.

QMS Processes Involved in Cybersecurity for Medical Devices

Quality Management System (QMS) processes play a critical role in ensuring the effectiveness and integrity of medical device cybersecurity measures. Several key QMS processes are involved in this endeavor:


Verification and Validation: When it comes to cybersecurity for medical devices, it's paramount to verify and validate all design input requirements and risk control measures. Security testing ensures that the implemented controls adhere to design specifications and prove effective in their operational environment.

Penetration testing plays a vital role in this context by assessing the robustness of systems by simulating real-world attacks, identifying vulnerabilities, and providing insights to strengthen defenses, ensuring robust protection against potential cyber threats.


Risk Management: QMS processes for risk management are essential for identifying, assessing, and mitigating cybersecurity risks associated with medical devices. By conducting thorough risk assessments, organizations can prioritize security measures and allocate resources effectively to address potential vulnerabilities.


Document Control: Document control processes within a QMS ensure that cybersecurity policies, procedures, and guidelines are documented, communicated, and maintained effectively. This includes managing documentation related to secure design principles, software updates, vulnerability management, and incident response protocols, as detailed in the previous section.


Change Management: QMS processes for change management are crucial for implementing updates, patches, and modifications to medical devices' cybersecurity features. This ensures that changes are evaluated, authorized, and implemented in a controlled manner to maintain the security and effectiveness of the devices.


Supplier Management: Effective supplier management processes are needed to ensure the security of third-party components and software used in medical devices. QMS processes for supplier evaluation, selection, and oversight help mitigate risks associated with outsourced components and ensure compliance with cybersecurity requirements.


Training and Competency Management: QMS processes for training and competency management ensure that personnel involved in the design, development, manufacturing, and maintenance of medical devices are adequately trained in cybersecurity principles and best practices. This helps promote a culture of security awareness and ensures that cybersecurity requirements are effectively implemented throughout the organization.


Infrastructure: The infrastructure process for cybersecurity for medical devices involves establishing and maintaining robust systems to safeguard critical assets and services. This includes implementing appropriate safeguards to protect against unauthorized access, data modification, or destruction. Custodial control of software source code throughout its lifecycle, along with measures to ensure information confidentiality, integrity, and availability, is essential. Access to assets and facilities should be restricted to authorized users, processes, or devices, with activities and transactions closely monitored. Technical security solutions should be managed and maintained to uphold system resilience and align with established policies. Detection processes should be established to promptly identify and respond to security threats, ensuring the overall security and reliability of the infrastructure.


Post-Market Surveillance: The post-market surveillance process involves continuously monitoring devices for potential vulnerabilities, threats, and cyber incidents once deployed in healthcare settings. The post-market surveillance process encompasses the examination of complaints, public databases, and similar devices on the market for potential cybersecurity failures. This proactive approach allows for the identification of cybersecurity issues that may not have been apparent during pre-market testing or development phases. By promptly detecting and addressing cybersecurity concerns post-market, manufacturers can mitigate risks to patient safety, protect sensitive health information, and ensure the ongoing reliability and effectiveness of medical devices in the face of evolving cyber threats.


By ensuring that all these typical QMS processes have cybersecurity-related considerations implemented and integrating these aspects into their daily activities, medical device manufacturers can establish a robust framework for managing cybersecurity risks and ensuring the safety and effectiveness of their medical devices.

Conclusion: Prioritizing Patient Safety and Privacy

As medical devices continue to evolve, ensuring their cybersecurity is paramount to safeguarding patient safety and privacy. Manufacturers must adopt a proactive approach to cybersecurity, integrating security measures into the design, development, and deployment of medical devices. Regulatory compliance, risk management, appropriate documentation and infrastructure, as well as training of stakeholders are essential for addressing cybersecurity challenges and fostering a culture of security in medical device manufacturing.


At QUAREGIA, together with our partners at PROREGIA, we can support you with prioritizing cybersecurity requirements for medical devices and mitigating risks posed by cyber threats to uphold the integrity of your medical devices. Protecting patient health and privacy is at the forefront of our efforts, for both newly released and legacy devices. Do not hesitate to contact us at to discuss custom-tailored solutions for cybersecurity for medical devices.

Last updated: 2024-03-01