Abstract

Post-market surveillance (PMS) under Article 88 of the EU 2017/745 Medical Device Regulation (MDR) and the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (SI 2024/1368) 44ZN regulates manufacturers on trend reporting.

This article presents a Lean Six Sigma (LSS) framework that uses the Define, Measure, Analyse, Improve, and Control (DMAIC) cycle, along with statistical process control (SPC) tools like c-, u- and p-charts, cumulative sum (CUSUM) charts and run charts (which are suitable for sparse and irregular complaint data), and an example of absorbable fixation device malfunctions, to show how setting control limits, selecting Western Electric or Nelson rules, and defining escalation thresholds can turn regulatory requirements into clear, auditable processes.

Applying LSS to PMS creates a continuous learning process that uses real-world data for timely, evidence-based improvements. This supports statistical monitoring, clear escalation steps, and a practical way to achieve compliance and improve device safety.