When compliance becomes your AI superpower: a MedTech story

Turning compliance into a catalyst for innovation

By rethinking how compliance, data and AI interact, Zühlke supported a global MedTech leader in transforming the way they deliver high-grade, regulation-compliant software.

Together, we built a development platform where AI accelerates architecture, verification and decision-making, all without compromising safety.

The project…

• Boosted alignment across architecture, requirements and verification
• Enabled AI-supported requirement checks, backlog generation and test scripting
• Strengthened compliance and quality without adding delivery overhead 

The challenge: Navigating fragmented systems in a regulated landscape

Our client, a pioneering force in the MedTech industry, was on a mission to modernise how they delivered a Class C medical platform. Operating under rigorous norms – including IEC 62304, ISO 13485, and FDA regulations – they needed airtight traceability, high documentation standards and full lifecycle transparency.

But the reality was not perfect.

• Architecture lived in isolated diagrams, scattered across documents
• Requirements were distributed across siloed systems
• Documentation lagged behind development, making traceability difficult and error-prone

Our client knew AI could help, but their ecosystem wasn’t ready. They faced the core paradox of regulated AI adoption: how to safely integrate intelligent tooling into a fragmented, compliance-critical environment without introducing risk. 

In short: the data was not AI-ready.

We began by addressing the root problem: the ecosystem’s fragmentation made the data unfit for intelligent automation. The first step was to make the client’s data AI-ready, so we:

• Migrated architectural models to a structured, text-based format using Structurizr DSL.
• Centralised architectural components, relationships, decisions and references to ADRs and requirements within a version-controlled Git repository.
• Exported product and system requirements from the QMS to CSV/Markdown and indexed them using Copilot’s local vector store for efficient retrieval.

Once this step was complete, CDM enabled a repeatable, governed pathway to introduce AI responsibly and incrementally.

This structured documentation landscape became the foundation for AI-augmented delivery, enabling intelligent tooling tailored to the needs of a regulated environment. By turning architecture, requirements and design rationale into machine-readable, mineable context, we unlocked powerful capabilities that improved decision-making, reduced rework and strengthened compliance alignment. 

AI now provides support in several key areas:

• Validating architectural fit before implementation: Surfacing conflicts with existing structures, layering rules or interface contracts, to ensure technical consistency and reduce rework.
• Detecting requirement contradictions early: Identifying inconsistencies across system-level and platform requirements in seconds prevents misalignment and avoids downstream defects.
• Drafting roadmaps and backlogs on demand: Generating initial epics and work breakdowns based on constraints and stakeholder input, to accelerate planning and facilitate better collaboration.
• Accelerating test script creation: Using Copilot and MCP servers to simulate device states and support verification workflows, to improve test coverage and shorten verification cycles.
• Maintaining end-to-end traceability: Mapping features, code and tests back to regulatory requirements, strengthening audit readiness and supporting compliance.

Most importantly, compliance stopped being a bottleneck and became a competitive advantage: 

• Traceability is now integrated across requirements, architecture and code, allowing the team to maintain regulatory readiness without slowing down delivery
• Small quality improvements that were previously too time-consuming are now achievable – and compound over time
• Teams are empowered to innovate, knowing regulatory requirements are continuously enforced by the system 

Setting a new standard for AI-augmented delivery in medical software

This project shows what happens when years-long experience in software engineering and software delivery in regulated environments meet the power of AI: compliance and innovation are treated as allies, not adversaries.

By transforming a fragmented legacy landscape into a connected, AI-ready system, Zühlke has helped the client harness the full potential of AI-augmented delivery in medical software.

Together, we turned a regulatory challenge into a strategic advantage – delivering better outcomes faster, and setting the stage for even more ambitious transformation.

From enabling AI-augmented verification tooling to unlocking real-time decision support, this collaboration shows how AI can become a future-proof platform for innovation, even in one of the most demanding software environments in the world.