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Avoiding ISO 14971 Mistakes — What Does Harm Really Mean? By Naveen Agarwal, Ph.D., principal and founder, Creative Analytics Solutions, LLC Identification of hazards, hazardous situations, and harms is foundational to analyzing the risks associated with a medical device. Yet, these terms are often misunderstood and misapplied in the industry. As a result, there is a lot of confusion and inconsistency in the implementation of risk management systems to meet the requirements of ISO 14971. In the first two parts of this three-part series, we discussed the terms “hazard” and “hazardous situation” in detail. In this third and final part, we will review the term “harm,” provide examples to illustrate how you can define potential harms applicable to your medical device, and explain how you can link them to relevant hazards and hazardous situations.

Naveen agarwalCreative analytics solutionsMedical dictionaryRisk managementMedical devicesRegulatory activitiesDindo classification systemRisk management toolநவீன் அகர்வால்படைப்பு பகுப்பாய்வு தீர்வுகள்மருத்துவ அகராதிஆபத்து மேலாண்மைமருத்துவ சாதனங்கள்ஒழுங்குமுறை நடவடிக்கைகள்டிண்டோ வகைப்பாடு அமைப்புஆபத்து மேலாண்மை கருவி