Meeting Japan’s Medical Device Cybersecurity Requirements with ELTON

Japan has adopted two key standards that shape how medical device manufacturers must design, build, and maintain safe and secure products. These are JIS T 2304, aligned with IEC 62304, and JIS T 81001-5-1, harmonized with IEC 81001-5-1. Together, they establish a framework that integrates software development discipline with comprehensive cybersecurity practices.

JIS T 2304 – Software Life Cycle Requirements

JIS T 2304 provides Japan’s implementation of IEC 62304, the international standard governing the software life cycle for medical devices. It requires manufacturers to demonstrate:

• Defined development processes covering planning, implementation, verification, and release

• Structured software maintenance, ensuring vulnerabilities and defects are addressed throughout the device’s operational life

• Risk management processes that trace software decisions back to patient safety outcomes

For connected medical devices, the challenge is not just building compliant software once but maintaining defensible evidence that risk is continuously managed.

JIS T 81001-5-1 – Cybersecurity Embedded in the Lifecycle

JIS T 81001-5-1 extends these principles by focusing specifically on cybersecurity in medical device software and systems. Harmonized with IEC 81001-5-1, it requires that cybersecurity is not treated as an afterthought but embedded throughout the product life cycle. Key expectations include:

• Identification of cybersecurity requirements during design

• Continuous risk analysis of vulnerabilities and threats

• Processes for secure implementation, verification, and postmarket monitoring

• Documentation that demonstrates defensible risk acceptance and mitigation decisions

This framework directly responds to the reality that modern medical devices operate in connected hospital environments, rely on wireless protocols, and interact with cloud or mobile applications.

How ELTON Helps Manufacturers Meet These Requirements

ELTON is purpose-built to align with these Japanese regulatory expectations while reducing the long-term cost of compliance. The platform provides:

• Software Bill of Materials (SBOM) Monitoring: Continuous visibility into open source and third-party components across device, mobile, and cloud systems, ensuring vulnerabilities are discovered and managed in line with JIS T 2304’s maintenance requirements.

• Risk and Vulnerability Contextualization: Rather than relying on generic CVSS scores, ELTON maps vulnerabilities to the device’s architecture and operational context, allowing manufacturers to make defensible “no-fix” or remediation decisions required under JIS T 81001-5-1.

• Lifecycle Traceability: From premarket testing through postmarket surveillance, ELTON maintains a living record of vulnerabilities, exploitability analysis, and mitigation actions, satisfying the documentation and traceability expectations of both standards.

• Chained Exploitability Analysis: ELTON goes beyond isolated vulnerability scoring, analyzing how vulnerabilities can interact and escalate within a device’s architecture—an essential practice to demonstrate robust risk management in connected systems.

Defensible Compliance, Lower Cost

Japan’s adoption of JIS T 2304 and JIS T 81001-5-1 makes it clear that medical device manufacturers must operate with cybersecurity and software quality as core lifecycle processes. ELTON enables companies to meet these requirements in a way that is traceable, auditable, and sustainable, avoiding the high costs of ad-hoc compliance or reactive patching.

With ELTON, manufacturers can demonstrate to regulators, customers, and auditors that their products are secure by design, properly maintained, and managed in accordance with international best practices.