Ferrocene becomes first Rust toolchain to achieve IEC 62304 qualification

Ferrous Systems, the leader in Rust solutions for safety-critical systems, is proud to announce that its flagship Rust toolchain, Ferrocene, has achieved IEC 62304 Class C qualification for medical device software. This milestone positions Ferrocene as an ideal solution for medical device developers wanting to streamline compliance efforts while ensuring the highest standards of safety and reliability.

“Qualifying Ferrocene under IEC 62304 demonstrates our commitment to advancing safety-critical software development through tools that enhance both security and performance,” said Florian Gilcher, managing director and co-founder of Ferrous Systems. “We’re excited to help medical device developers leverage the power of Rust to create innovative healthcare solutions that meet the highest industry standards.” 

Why Rust for medical devices?
Rust is rapidly gaining traction in the medical device industry due to its robust memory safety and concurrency features, which are critical for ensuring reliability and performance in safety-critical applications. Rust’s strong track record in cybersecurity also aligns with increasing regulatory demands, including 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. 

About Ferrocene
Ferrocene is the first open-source qualified Rust compiler toolchain for safety- and mission-critical applications. It is qualified to automotive (ISO 26262, ASIL-D), industrial development (IEC 61508, SIL4) and medical (IEC 62304, Class C) standards, with more to come. The latest release, Ferrocene 24.11, is currently qualified for use on x86-64 Linux and Armv8-A (bare metal), as well as 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.