Medical Devices
Codethink applies deep expertise from safety-critical industries to accelerate medical software innovation. Our mission is to help clients meet rigorous regulatory requirements, safeguard patient outcomes, and maintain business integrity.
A single failure in the medical devices industry could cost an average of $3.5 million in direct losses—before factoring in liability exposure, brand damage, and product recalls. Navigating standards like IEC 62304 and ISO 14971 is not optional: it’s essential.
Our approach leverages trusted open source software and domain-specific safety practices to help clients deliver compliant, high-quality products to market faster and with confidence.
Want to learn how we can support your next-generation medical device? Let’s talk.
How Codethink Supports Medical Device Compliance
Software compliance isn’t just a regulatory hurdle in the medical device industry–it’s a reputational imperative for patient safety. Failure to manage it effectively risks costly delays, recalls, and brand erosion. Done right, it becomes a competitive advantage.
Codethink’s Trustable Software Framework and engineering approach are purpose-built to ensure end-to-end alignment with IEC 62304, ISO 14971, and other global standards throughout the product lifecycle.
How we help you build safer, smarter, and compliant medical products:
- Accelerating time to patch and push updates
- Managing complex real-time system demands
- Driving continuous testing and validation
- By scaling software integration with confidence
- Support for over-the-air updates
- Supporting integration tests with emulation
- Eliminating development bottlenecks
Rethinking Medical Device Safety for a Continuous Delivery World
Traditional safety certifications no longer keep pace with the speed of modern software development. The Trustable Software Framework (TSF) offers a new paradigm to assessing risk–one that treats safety as a transparent, auditable process, not a checkbox.
Originally developed by Codethink and now an Eclipse Foundation open source project that Codethink leads, TSF brings a risk-based, future-ready model to the continuous delivery of safety-critical software. At its core are the Trustable Tenets–a foundation for building resilient, compliant systems in fast-moving industries like medical devices.
The first three tenets drive Codethink’s approach:
- Provenance: Codethink helps clients eliminate risk from Software of Unknown Provenance (SOUP) by ensuring that every part of their software meets safety standards.
- Construction: How software is constructed determines its behaviour. We guide clients through robust development strategies that ensure predictable, reliable performance from day one.
- Change: Software evolves, and safely managing that change is non-negotiable. Codethink supports lifecycle updates and patches while minimising risk and maintaining compliance.
→ Discover the other Trustable Tenets
Bottom line: safety isn’t static. It’s engineered.
Explore how Codethink’s Trustable Software Framework keeps your products secure, scalable, and ready for what’s next.
Explore Related Resources
Codethink has a history in the medical devices sector. The Bloodlight project involved designing an open-hardware device for measuring heart rate, aiming to avoid common problems with existing devices.
→ Explore articles related to Bloodlight
In 2019, we partnered with York Instruments to modernise a legacy Magnetoencephalogram (MEG) system. By replacing obsolete components with scalable, maintainable alternatives, we helped York Instruments extend the product lifecycle and eliminate OEM part dependencies. Learn more about the project here.
Other articles/resources
- Explore all Medical Devices and Bloodlight articles
- Blog post: ‘The Case For Open Source Software In The Medical Industry’
- Blog post: ‘Speed Up Embedded Software Testing with QEMU’
- Blog post: Achieving Long-Term Maintainability with Open Source
- Codethink and Embedded Systems
- Codethink and Build Engineering
- Reports & White Papers
Build Safer Medical Devices with Confidence
Looking to build safer, compliant medical software? Discover how Codethink can help support your products.
→ Contact Codethink
