Medical Device Software: February 2026 FDA Cybersecurity Update

Medical device software is subject to an increasingly demanding regulatory landscape on both sides of the Atlantic.

In Europe, manufacturers must comply with the Medical Device Regulation (MDR), which explicitly requires state-of-the-art development practices, including life-cycle management, risk management, verification and validation, and information security. For software, IEC 62304 defines the required life-cycle processes, while IEC 81001-5-1 extends those requirements to cover cybersecurity activities throughout the product life cycle. Notably, IEC 81001-5-1 was clarified by Interpretation Sheet 1 in December 2025, reinforcing expectations on security life-cycle evidence.

In the United States, FDA requirements combine the long-standing General Principles of Software Validation with 21 CFR Part 820 (Quality System Regulation), which mandates validation of software used in production and quality systems. In February 2026, FDA updated its cybersecurity guidance, further strengthening expectations around Secure Product Development Frameworks (SPDFs), traceability, vulnerability management, and objective verification evidence.

Meeting these overlapping requirements demands rigorous processes and strong technical foundations. The ECLAIR Software Verification Platform and its TÜV-audited Functional Safety ecosystem provide systematic static analysis, coding-standard enforcement (including MISRA C:2025 and MISRA C++:2023), architectural constraint verification, traceability support, and CI/CD integration, producing auditable, regulator-ready evidence.

A comprehensive overview of regulatory developments through February 2026, including the updated FDA cybersecurity guidance, is available in the brochure below.

MEDICAL DEVICES COMPLIANCE 2026

The document provides a clear analysis of current expectations for software life-cycle management, cybersecurity, and verification evidence, and includes a requirement-by-requirement mapping of applicable standards to corresponding ECLAIR capabilities and verification outputs, highlighting how ECLAIR enables audit-ready compliance evidence.

Interested in understanding how these regulatory updates impact your software development processes?
Contact us to schedule a discussion with our experts and explore how ECLAIR can support your compliance strategy.