‘Measurement, Analysis & Improvement’ Refer to / taken from Ensuring Compliance: Navigating the EU MDR for Drug-Device Combination Products

This item addresses Measurement, Analysis and Improvement (ISO 13485 §8.5) and requirements for associated statistical analysis (ISO 13485:2016 §7.3.6, §7.3.7, §7.5.6, §8.1 and §8.4)

Download for further reading -> CPDS global QMS : Measurement, Analysis and Improvement