Escaping the hidden costs of inconsistent CI/CD in regulated systems

In safety-critical industries like MedTech, software isn’t just code, it’s a regulated part of the product. Every build, test, and update must meet compliance requirements and pass security checks. But many organizations still rely on manual, inconsistent workflows that delay approvals and increase risk.

The problem: Compliance bottlenecks and security gaps

We recently worked with a medical device company dealing with growing challenges around regulatory compliance, software integration, and security validation. Their manual build process introduced inconsistencies, making it difficult to demonstrate compliance with FDA guidelines and standards like the EU Cyber Resilience Act (CRA).

Security testing was done late in the cycle, often manually and frequently revealed issues after software had been integrated, requiring costly rework and delays. As a result, regulatory approvals were delayed by 6+ months, putting product launches and revenue targets at risk.

The solution: Security-focused embedded CI/CD automation

To address these issues, the company adopted the IAR toolchain for CI/CD and embedded security, designed to bring automation, consistency, and security into the heart of embedded development.

The transformation was substantial:

• 50% faster build times, speeding up regulatory documentation and approval cycles
• Automated compliance checks aligned with NIST, CRA, and ETSI security standards
• 80% reduction in debugging time, eliminating late-stage software defects before they became showstoppers

By integrating IAR into their CI/CD pipeline, the team could now validate, test, and secure their software continuously, not just at the end of the cycle.

Why security-first CI/CD is a must

Cybersecurity and compliance are no longer optional in embedded development, they are core requirements. As connected medical devices and IoT systems proliferate, so do the risks and regulatory expectations.

Thought leaders like Jacob Beningo emphasize this shift in frameworks such as the 7-Step Guide to Modernizing Embedded Systems, which highlights the importance of automated, security-integrated workflows for long-term success.

How IAR makes secure embedded CI/CD possible

IAR enables embedded teams to build compliance and security into their workflows´, not bolt them on later.

Here’s how:

• Automated static and dynamic analysis with C-STAT and C-RUN, ensuring early detection of vulnerabilities and coding standard violations
• Reproducible, containerized builds that eliminate dependency conflicts and ensure consistent, secure output every time
• Integration with GitHub, GitLab, Jenkins, and Azure DevOps, so testing and compliance checks happen automatically at every commit

This allows security and compliance to become part of the development DNA, rather than a burden at the end of the project.

The outcome: Compliance at speed and scale

With IAR’s security-first DevOps workflow, the medical device company is now:

• Meeting global regulatory requirements faster and with less effort
• Reducing compliance costs through automation
• Delivering more secure, higher-quality products to market on time

Final thoughts: Modernizing embedded development with IAR

Across industries, embedded development is evolving and fast. Frameworks like Jacob Beningo’s 7-Step Framework to Modernize Your Embedded Systems Practices provide a clear path forward, but implementing these best practices requires the right tools.

IAR delivers on this by providing a platform purpose-built for embedded development, enabling teams to:

• Automate embedded CI/CD workflows with cloud-enabled solutions
• Simplify compliance with pre-certified functional safety tools
• Develop across architectures, avoiding vendor lock-in
• Integrate security validation, aligning with modern cybersecurity regulations

Looking to future-proof your embedded development?

Whether your priority is faster certification, improved security, or global scalability, IAR is your partner in embedded success.

Join our on demand webinar, Breaking the CI/CD bottleneck: Scaling embedded DevSecOps with containers & automation, to discover how you can streamline workflows, accelerate certification, and simplify compliance with the help of IAR’s safety-certified platform.

Working in a smaller team? You might find the on demand webinar Surviving without a DevOps team: CI/CD, debugging, and containers for embedded teams, a better fit for your needs.