Avoiding ISO 14971 Mistakes â 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.