Real Project — a complete ISO 14971 risk management file for a hypothetical ambulatory infusion pump, from hazard identification through overall benefit-risk conclusion.
This project builds a complete ISO 14971:2019 risk management file, end to end, for a hypothetical Class II ambulatory infusion pump — a portable, battery-powered device delivering a programmed drug or fluid rate to a patient over hours to days outside a hospital setting — the way one would need to exist before design freeze.
It works through hazard identification specific to an infusion pump, risk estimation using a worked severity-times-probability scoring framework, risk control selection following the mandatory hierarchy (inherent safety by design first, protective measures second, warnings last), residual risk evaluation, and an overall benefit-risk conclusion written in the form suitable for a design history file and a 510(k) or CE technical file submission, directly applying the ISO 14971 process built in Module 3.