Why Medical Device Manufacturers Must Validate Their Cybersecurity Tools

Introduction

In the medical device industry, every process and every tool used in design and development must meet rigorous quality standards. That includes not just testing equipment or software development tools—but also cybersecurity tools. Under FDA’s Quality System Regulation (21 CFR Part 820) and international standards such as ISO 13485 and IEC 62304, manufacturers are required to validate any software used in production or quality systems to ensure it performs as intended.

Cybersecurity tools are no exception. When you use scanners, vulnerability management platforms, or analysis tools to generate evidence for your regulatory submission, those results become part of your design history file (DHF). If those tools are not validated, the data they produce cannot be considered reliable or compliant under FDA’s quality system expectations.

This is why ELTON was designed as a pre-validated solution—purpose-built for medical device manufacturers, aligned with FDA guidance, and already using an FDA-approved process for vulnerability identification, scoring, and documentation.

What Does Validation Mean?

In regulatory terms, validation means providing documented evidence that a process or software tool consistently produces results that meet predetermined specifications and quality attributes.

In other words, validation answers three key questions:

1. Does the tool work as intended?

2. Does it produce accurate, reproducible results?

3. Can its output be trusted in a regulated submission or audit?

The FDA requires manufacturers to validate all software tools used to develop, verify, or maintain a medical device—especially those whose outputs affect product safety, performance, or regulatory documentation. That includes cybersecurity tools that generate vulnerability data, risk analyses, or test evidence.

Why Cybersecurity Tools Must Be Validated

Cybersecurity has now become an integral part of device safety. The FDA’s 2025 Premarket Cybersecurity Guidance states that vulnerability assessments, testing reports, and SBOM analyses form part of the device’s safety and effectiveness demonstration.

However, if the tools that generate those results are not validated, they introduce risk to the integrity of your quality system and may cause your submission to be delayed or questioned. Common issues include:

• Inconsistent or unverifiable test results: If two scans produce different findings, which one is correct?

• Non-traceable data sources: Without validation, it’s unclear how vulnerabilities were identified or classified.

• Regulatory non-compliance: FDA auditors may reject or question evidence derived from unvalidated tools, as it fails to meet the expectations under 21 CFR 820.70(i) (software used in production or the quality system must be validated for intended use).

Validation ensures your cybersecurity activities—like penetration testing, vulnerability scanning, and SBOM analysis—are not just technically sound but regulatorily defensible.

ELTON: A Pre-Validated Solution

ELTON is built specifically for regulated device manufacturers. It is pre-validated for use within your Quality Management System (QMS), eliminating the burden of performing independent tool validation.

Our platform applies an FDA-approved Medical Device Development Tool (MDDT) process for vulnerability evaluation and scoring, ensuring that its outputs are recognized and defensible in premarket and postmarket regulatory submissions.

ELTON’s validation includes:

• Documented software validation package that aligns with FDA’s expectations under 21 CFR 820.70(i) and ISO 13485:2016 §7.6.

• Process traceability from input to output, showing how vulnerabilities are analyzed, scored, and triaged.

• Continuous verification through automated regression testing and expert oversight to ensure consistent, reproducible results.

In short, ELTON provides a validated environment where vulnerability testing, exploitability scoring, and risk documentation are fully aligned with your QMS and ready for regulatory review.

Why This Matters

Failing to validate your cybersecurity tools can compromise the credibility of your submission and delay market approval. A non-validated tool may be viewed as introducing uncontrolled variability into your product’s risk management process. By contrast, using validated tools like ELTON provides:

• Regulatory confidence: Data and reports that meet FDA and global expectations.

• Audit readiness: Validation records that demonstrate your tools perform as intended.

• Efficiency: Elimination of redundant internal validation work.

• Consistency: Reproducible, architecture-aware cybersecurity results integrated with your device lifecycle.

Conclusion

In the world of medical device cybersecurity, validation equals trust. Every analysis, report, and decision depends on the reliability of the tools you use. The FDA expects manufacturers to prove that their cybersecurity tools are validated for their intended use—just like any other software in the design and development process.

ELTON is a pre-validated, FDA-aligned cybersecurity platform that ensures your vulnerability testing and analysis results are accurate, traceable, and audit-ready. By leveraging an FDA-approved process, ELTON streamlines your regulatory path and gives you confidence that your cybersecurity program meets both technical and quality system requirements.

ELTON: Validated for Compliance. Trusted for Results.