IEC 81001-5-1 Compliance for Medical Devices

Cybersecurity is now a core requirement for connected medical technologies, not a last-minute consideration. Medical device manufacturers must demonstrate that their health software and connected technologies are secure, resilient, and developed with security in mind. IEC 81001-5-1 is the emerging global cybersecurity standard for medical devices, setting clear expectations for integrating cybersecurity into the secure development lifecycle of software and IT systems used in healthcare.

Intertek offers end-to-end IEC 81001-5-1 compliance services to help you meet global regulatory expectations, including those from the FDA, EU MDR, and Japan’s Ministry of Health. Whether you’re developing new devices or modernizing legacy systems, our third-party assessments provide objective, credible validation of your security posture.

What Is IEC 81001-5-1?

IEC 81001-5-1 is a process-based cybersecurity standard tailored specifically for medical technologies. Closely aligned with IEC 62443-4-1, this standard outlines how to embed cybersecurity into the full product development lifecycle, from design and coding to testing, deployment, and post-market support.

Unlike product certification schemes, IEC 81001-5-1 focuses on your development process, allowing a single secure lifecycle to support multiple devices. This is especially advantageous for manufacturers with large product portfolios or those expanding into multiple global markets.

The standard consists of 73 clauses (including transitional options) and covers topics such as secure coding practices, vulnerability analysis, software composition analysis, risk-based remediation, and independent validation.

Why It Matters Now

Adoption of IEC 81001-5-1 is accelerating. Japan already mandates compliance, the FDA recognizes the standard in regulatory filings, and the European Union is moving toward formal adoption. Meanwhile, cyberattacks on healthcare systems continue to rise, impacting devices used in hospitals, clinics, and increasingly, in the home.

Failure to comply with IEC 81001-5-1 can result in delayed approvals, lost business opportunities, and increased risk exposure. Demonstrating compliance not only protects patients and data but it gives regulators, procurement teams, and healthcare providers confidence in your product.

Intertek’s IEC 81001-5-1 Compliance Solution

Intertek offers a structured, proven process to help manufacturers achieve compliance, whether you're following the full clause-based approach or pursuing the Annex F transitional path for legacy devices. We guide your team through:

• Review and alignment of your software development lifecycle with all applicable clauses
• Gap assessments and documentation mapping against the standard’s requirements
• Guidance on independent vulnerability testing, including fuzz testing and penetration testing
• Evaluation of third-party software and software composition analysis
• Risk management review, including risk-based remediation timelines
• Verification of Conformance, issued by a trusted third-party assessor

Our approach is iterative and collaborative. Most clients complete the process in 8 to 12 weeks, depending on document readiness. We maintain separation between our consulting and assessment teams to preserve objectivity and regulatory credibility.

Full vs. Transitional Compliance

IEC 81001-5-1 offers two pathways to compliance:

1. Full Compliance involves demonstrating alignment with all clauses, including secure development, testing, threat modeling, and documentation controls.
2. Transitional Compliance (Annex F) is ideal for in-market or legacy devices. It allows manufacturers to justify exceptions based on a documented risk assessment. While this approach may seem simpler, it still requires rigorous analysis and validation, especially for devices developed before cybersecurity became a regulatory priority.

In both paths, documentation must reflect how the organization identifies threats, manages software updates, tests for vulnerabilities, and separates duties between development and validation teams.

One Standard, Many Devices

One of the most powerful aspects of IEC 81001-5-1 is its process-level focus. If your team uses the same secure development lifecycle across multiple devices, a single conformance assessment may cover them all. This scalability is especially important for manufacturers with distributed teams, multiple product lines, or recent acquisitions that need to consolidate cybersecurity frameworks.

Intertek works with organizations to harmonize their processes and ensure consistency across product families. We help you identify redundancies, align your cybersecurity risk management approach with global best practices, and prepare documentation that can support your full regulatory strategy.

Why Choose Intertek?

With decades of experience in medical device testing and certification, and a specialized team focused on cybersecurity for health software and connected technologies, Intertek is uniquely positioned to support your IEC 81001-5-1 journey.

We combine regulatory insight, technical depth, and real-world assessment expertise. Our assessors have deep familiarity with both IEC 81001-5-1 and IEC 62443, and our secure development reviews have helped medical device companies demonstrate compliance across North America, Europe, and Asia.

When you partner with Intertek, you gain a strategic ally committed to helping you build secure, resilient products and meet evolving regulatory expectations with confidence.

Get Started

The journey to IEC 81001-5-1 compliance starts with a conversation. Whether you're preparing for FDA submission, pursuing CE marking, or looking to modernize your risk posture, Intertek can help you take the next step.