Harish Gyanaji
Harish Gyanaji, MS MTOPRA, is a Six Sigma Black Belt and quality market and post-market surveillance expert in the US
JournalLean Six Sigma in post-market surveillance: Insights for EU 2017/745 MDR Article 88 and Great Britain SI 2024/1368 (44ZN) trend reporting compliance
This article demonstrates how Lean Six Sigma principles can strengthen post-market surveillance systems for medical devices, enabling manufacturers to detect statistically significant trends in non-serious incidents and meet evolving EU MDR Article 88 and UK SI 2024/1368 44ZN requirements through structured DMAIC methodology and statistical process control