• Avoiding ISO 14971 Mistakes — What Does “Harm” Really Mean?

    In the first two parts of this three-part series on ISO 14971 terminology, 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. 

  • Avoiding ISO 14971 Mistakes — Are You Accurately Defining “Hazardous Situations”?

    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 part of this three-part series, we discussed the term “hazard” in detail. In this second part, we will review the term “hazardous situation” and provide examples to illustrate how you can define potential hazardous situations during risk analysis of your medical device.

  • Avoiding ISO 14971 Mistakes — Do You Really Understand The Term “Hazard”?

    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. This first part of a three-part video series reviews the term “hazard” in detail, highlights areas of confusion, and illustrates a few examples to facilitate a better understanding and its application in risk analysis. 

  • ISO 14971: Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices

    Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.


Naveen Agarwal

Naveen Agarwal began his consulting practice in 2017, with the goal of helping medical companies build safe products through quality systems that are not only compliant to regulatory requirements but also focused on the needs of patients and physicians. He has 20 years of industry experience in leadership roles ranging from R&D to product quality and business analytics. As a result, he has a broad and deep expertise in all of the core functions involved in the lifecycle of medical products. His consulting practice focuses on problem-solving in the areas of risk management, quality systems, customer experience, and quality culture. You can view other videos by Agarwal on his YouTube channel, email him, and connect with him on LinkedIn.