Risk Management for Agile Medical Device Software Development: Applying AAMI TIR80002‑1 and TIR45 in Practice

As medical devices become increasingly software‑driven, risk management approaches often struggle to keep pace with rapid iteration, evolving requirements, and continuous integration cycles. This session demonstrates how Agile development can be effectively harmonized with ISO 14971 by applying the practical guidance of AAMI TIR80002‑1 and AAMI TIR45. This session frames risk management activities as dynamic, sprint‑aligned processes that embed safety thinking directly into Agile workflows.

Through a detailed real‑world case study, the presentation illustrates how risk controls, usability considerations, safety impact assessments, and verification activities can be incrementally integrated into sprints without compromising regulatory expectations or design control rigor. Attendees will learn practical techniques for maintaining end‑to‑end traceability, updating risk files iteratively as design decisions evolve, and ensuring that safety‑critical tasks remain visible and prioritized throughout development.

The session will also highlight practical tools such as sprint‑level risk reviews, lightweight hazard backlogs, integrated verification planning, and cross‑functional safety checkpoints that help teams operationalize Agile while preserving the intent of ISO 14971, IEC 62304, and FDA expectations for software documentation. Workflow examples, templates, and lessons learned from implementation across connected device platforms will provide a grounded roadmap for organizations transitioning from traditional models to Agile‑enabled development.

Participants will leave with actionable strategies to build Agile processes that are both fast and safe, ensuring that patient safety, regulatory compliance, and engineering pace reinforce one another across the software lifecycle.