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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 Agarwal , Creative Analytics Solutions , Medical Dictionary , Risk Management , Medical Devices , Regulatory Activities , Dindo Classification System , Risk Management Tool , நவீன் அகர்வால் , படைப்பு பகுப்பாய்வு தீர்வுகள் , மருத்துவ அகராதி , ஆபத்து மேலாண்மை , மருத்துவ சாதனங்கள் , ஒழுங்குமுறை நடவடிக்கைகள் , டிண்டோ வகைப்பாடு அமைப்பு , ஆபத்து மேலாண்மை கருவி ,