Ferrocene Becomes First Rust Toolchain to Achieve IEC 62304 Qualification

By Tiera Oliver

Associate Editor

Embedded Computing Design

January 22, 2025

News

Ferrocene Becomes First Rust Toolchain to Achieve IEC 62304 Qualification

BERLIN Ferrous Systems announced that its flagship Rust toolchain, Ferrocene, has achieved IEC 62304 Class C qualification for medical device software, making it an ideal solution for medical device developers wanting to streamline compliance efforts while ensuring high safety and reliability standards.

Ferrocene is an open-source qualified Rust compiler toolchain for safety- and mission-critical applications. It is qualified for automotive (ISO 26262, ASIL-D), industrial development (IEC 61508, SIL4), and medical (IEC 62304, Class C) standards. The latest release, Ferrocene 24.11, is currently qualified for use on x86-64 Linux and Armv8-A (bare metal), and QNX Neutrino 7.1.0 for x86-64 and Armv8-A. The source code of Ferrocene is fully open source under the MIT or Apache-2.0 licenses, including the full qualification documents.

Rust is gaining traction in the medical device industry with robust memory safety and concurrency features critical for ensuring reliability and performance in safety-critical applications. Rust’s use in cybersecurity also aligns with regulatory demands like Section 524B of the FD&C Act, which requires manufacturers to maintain a strong cybersecurity posture, and the FDA’s final guidance on cybersecurity in medical devices, emphasizing the importance of secure software development practices, risk management, and cybersecurity measures throughout the medical device lifecycle. 

Key benefits of Rust: 

  • Interoperability with C/C++: Utilizing the bindgen tool, Rust developers can automatically generate bindings to interface with existing C/C++ libraries, enabling seamless integration of pre-existing code while maintaining Rust’s strong safety and concurrency guarantees.  
  • Memory Safety for Bare Metal Systems: Rust's ownership model, which manages memory safely and efficiently at compile time without requiring a garbage collector, helps developers avoid undefined behavior and eliminates runtime overhead. 
  • Predictable Performance: Rust’s memory model provides consistent performance, essential for real-time responses in critical medical applications.  

For more information, visit: Ferrous Systems 

Tiera Oliver, Associate Editor for Embedded Computing Design, is responsible for web content edits, product news, and constructing stories. She also assists with newsletter updates as well as contributing and editing content for ECD podcasts and the ECD YouTube channel. Before working at ECD, Tiera graduated from Northern Arizona University where she received her B.S. in journalism and political science and worked as a news reporter for the university’s student led newspaper, The Lumberjack.

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