Case Study: Medtronic achieves scaled Agile, end-to-end traceability, and regulatory compliance with Intland Software's codeBeamer ALM

How exactly this MedTech giant has implemented Agile processes using Codebeamer

Medtronic’s Neuromodulation department, part of the world’s largest standalone medical technology company, needed to modernize its software development processes and meet strict regulatory requirements. The team was hampered by a fragmented legacy toolchain (multiple ALM, versioning, document and testing tools), which made end-to-end traceability, process transparency, document control and FDA‑ready audit reporting difficult and time-consuming.

In April 2015 Medtronic deployed codeBeamer ALM as a single, integrated platform to unify requirements, workflows, test management, document control and traceability (including FDA Title 21 CFR Part 11 e‑signatures). The solution rolled out quickly, scaled to 250+ developers, cut validation and reporting effort, improved process visibility and compliance, and helped the department reshape its development processes—delivering rapid adoption and measurable gains in predictability, quality and audit readiness.

Medtronic

Sarb Singh-Kaur

Director of Patient Care Software