Cybersecurity Requirements in Medical Devices
Medical devices increasingly rely on software, connectivity, and data exchange to deliver clinical functionality and improve patient outcomes. As a result, cybersecurity has become a core requirement for medical device safety, regulatory compliance, and market access.
Manufacturers of medical devices and software as a medical device (SaMD) must address cybersecurity risks throughout the product lifecycle, from design and development to deployment, maintenance, and post‑market surveillance. Regulatory expectations emphasize risk management, secure design, protection of sensitive data, and the ability to detect, respond to, and remediate vulnerabilities.
In practice, cybersecurity requirements for medical devices are shaped by a combination of regulations and standards.
Medical Device Cybersecurity Standards and Regulatory Frameworks
Medical device cybersecurity requirements are defined by regulatory frameworks and harmonized standards that integrate cybersecurity into overall device safety, performance, and risk management processes.
EU Medical Device Regulation (MDR – EU 2017/745) and In Vitro Diagnostic Regulation (IVDR – EU 2017/746)
The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require manufacturers to address cybersecurity risks as part of general safety and performance requirements. Cybersecurity is assessed within risk management, software lifecycle processes, technical documentation, and post‑market activities, including vulnerability handling and corrective actions.
The regulations require manufacturers to apply appropriate cybersecurity measures reflecting the state of the art, while taking into account the principles of risk management throughout the device lifecycle, including protection against unauthorized access to sensitive and personal data processed by electronic programmable systems and software‑based medical devices.
ISO 14971 – Medical Device Risk Management
ISO 14971 defines the framework for identifying, evaluating, controlling, and monitoring risks throughout the lifecycle of a medical device.
In the context of cybersecurity, ISO 14971 is used to assess security‑related risks that may impact patient safety, clinical performance, or data integrity, and to document the rationale for risk control measures and residual risk acceptability as part of regulatory submissions. Guidance documents such as AAMI TIR57 are commonly used to support the application of cybersecurity risk management principles to medical devices and health software.
IEC 62304 – Medical Device Software Lifecycle Processes
IEC 62304 specifies lifecycle requirements for medical device software, including development, maintenance, and problem resolution.
Cybersecurity considerations are integrated into software architecture, implementation, change management, and maintenance activities, particularly for connected devices and SaMD.
IEC 81001‑5‑1 – Health Software Cybersecurity
IEC 81001‑5‑1 focuses specifically on cybersecurity for health software, including software embedded in medical devices and standalone health software.
It defines requirements for secure design, vulnerability management, incident handling, and secure updates, supporting alignment with regulatory expectations under MDR and IVDR.
Common Criteria (ISO/IEC 15408) – Security Certification for Medical Devices
Common Criteria (ISO/IEC 15408) is an internationally recognized framework for the independent security evaluation and certification of IT products and components, including security‑relevant elements used in medical devices and health software.
In the medical device sector, Common Criteria certification may be applied to security‑critical software and hardware components, communication modules, and embedded systems where independent security assurance is required to support regulatory expectations, customer requirements, or market access. Common Criteria certification provides formal recognition under an international certification scheme, with certificates recognized across multiple regions, including the EU, the United States, the United Kingdom, and other global markets.
ISO/IEC 27001 and ISO/IEC 27002 – Information Security Management
ISO/IEC 27001 and ISO/IEC 27002 provide requirements and guidance for establishing and maintaining information security management controls. In the medical device context, these standards are commonly applied to development environments, supporting IT systems, and organizational processes that handle sensitive medical and patient data, complementing device‑level cybersecurity controls.
Software and Medical Device Cybersecurity Evaluation
Medical devices and health software increasingly rely on complex software and embedded hardware components that require cybersecurity evaluation beyond high‑level compliance with standards.
QIMA provides cybersecurity evaluation services for medical devices and SaMD, supporting the identification, analysis, and remediation of vulnerabilities in software, firmware, and system architectures. Evaluation activities are tailored to the device classification, intended use, deployment environment, and applicable regulatory requirements.
Cybersecurity evaluation services may include:
Vulnerability assessment of medical device software and embedded systems
Penetration testing of connected medical devices and SaMD
Secure design and architecture review
Remediation guidance and re‑testing support
Cybersecurity evaluation may also include assessment of the development environment, covering access control, tooling, build processes, and threat modelling activities to support secure software development and regulatory expectations under MDR and IVDR.
QIMA Cybersecurity Solutions for Medical Devices
QIMA supports medical device manufacturers with a comprehensive set of cybersecurity services aligned with regulatory and clinical expectations.
Our solutions include cybersecurity gap assessments, risk management support, software and system security evaluations, and preparation for regulatory conformity assessment. We work with development and quality teams to integrate cybersecurity into existing design controls and quality management systems, supporting efficient compliance without unnecessary disruption to development timelines.
QIMA’s approach helps manufacturers demonstrate cybersecurity compliance as part of overall device safety and performance.
Examples of Medical Devices and Software in Scope
QIMA provides cybersecurity services for a wide range of medical technologies, including:
Connected medical devices and systems
Software as a medical device (SaMD)
In vitro diagnostic (IVD) software and instruments
Medical device firmware and embedded systems
Clinical and health IT applications supporting medical devices
Why QIMA for Medical Device Cybersecurity
QIMA combines cybersecurity expertise with experience in medical device testing, inspection, and certification. Our multidisciplinary capabilities allow manufacturers to address cybersecurity alongside safety, quality, and regulatory requirements through a single partner.
With global reach and knowledge of regulated healthcare markets, QIMA helps medical device manufacturers manage cybersecurity requirements consistently across products and regions.
Resources
Explore practical resources to support medical device cybersecurity compliance and secure health technology development.
Gap Analysis Infographics for Medical Devices Regulation - Infographic
Risk Analysis Infographics for MDR Cybersecurity - Infographic
Talk to Our Medical Device Cybersecurity Experts
Whether you are developing connected medical devices, preparing software for regulatory approval, or strengthening post‑market cybersecurity processes, QIMA can support your organization.
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FAQs
Do MDR and IVDR include cybersecurity requirements?
Yes. Both regulations require manufacturers to address cybersecurity risks as part of overall device safety and performance, including risk management and post‑market activities.
Does cybersecurity affect medical device certification?
Yes. Cybersecurity considerations are increasingly reviewed as part of conformity assessment and market surveillance activities.
How does cybersecurity apply to software as a medical device (SaMD)?
Cybersecurity is a critical aspect of SaMD safety and performance. Manufacturers must manage risks related to data protection, access control, and vulnerability handling throughout the software lifecycle..