Case study

AI enablement for three departments in a regulated business

We delivered the same workshop three times, to Operations, Regulatory Affairs and Software Quality Assurance, and rebuilt it each time around that department’s own work process and the compliance constraints it works under.

Departments: Operations, Regulatory Affairs, Software Quality Assurance
Format: One workshop design, delivered three times
Preparation: Discovery per department
Frameworks: Three paths to AI value, RIGHT prompting
Hands-on: The client's own approved AI tools

The situation

The workshop was for three departments in a medical device business, and each does very different work: Operations runs project management for new components, Regulatory Affairs prepares submissions, and Software Quality Assurance produces test documentation. All three had heard what generative AI can do in general, but they had not yet seen it used in a process where outputs are subject to audit, traceability and regulatory review.

What we did

We ran discovery with each department first, so each delivery used that department’s own work as its examples.

Business value opportunities with generative AI: the three paths, applied by participants to their own function before any tool was opened.
Frameworks, tools and key concepts: what the technology does across text, visual, audio and data, where the current limits are, and what the EU AI Act means for a regulated manufacturer.
Using generative AI in the work: the department’s own process, mapped and then re-mapped with AI applied stage by stage.
AI agents: the difference between a copilot, a tool and an agent, and which of the three a given task needs.

The method: mapping the process with and without AI

The core of each session was a pair of views of the same work. First, how we do things: the department’s process laid out stage by stage, with the inputs, outputs, roles and data sources at each one. Then, how we do things with generative AI: the same stages with a specific application named at each. The participants worked from a process they already owned and marked the points where AI could be applied.

What the regulated setting changed

Most of the applications the departments identified were shaped by compliance requirements. Software Quality Assurance surfaced regulation alignment for test protocols, traceability matrix generation, duplicate defect detection, and formatting to regulatory standard. Operations surfaced supplier matchmaking, submission drafting, and root cause summarization after launch. In all three departments, the most valuable applications were in documentation, traceability and review, because that is where much of the effort goes and where the standard is clearly defined.

Hands-on, in their own tools

Prompting practice used the RIGHT framework and the zero-shot to few-shot ladder. Participants practiced inside the company’s own approved AI chatbot. The later sessions added live application building.

What participants left with

Participants left with a workshop companion guide and a set of AI use cases identified for their own department during the session. They also had hands-on experience in the tools they are permitted to use, and a resource page with the materials, prompts and links from both sessions.