Medical Device Hazard Analysis Under FDA QMSR: A Practical ISO 14971 Guide

Overview

Hazard analysis has always played an important role in medical device safety. Under FDA’s Quality Management System Regulation, risk information now carries wider significance across the quality system and can influence decisions involving suppliers, validation, complaints, CAPA, change control, and postmarket surveillance.

Medical device companies must be able to show more than a completed risk table. They need a clear and consistent process for identifying hazards, evaluating potential harm, selecting appropriate controls, documenting risk decisions, and using new quality and postmarket information to keep those decisions current.

Several techniques can be used to evaluate risk, including Failure Modes and Effects Analysis, Fault Tree Analysis, and Hazard Analysis. Hazard Analysis, as described in ISO 14971, provides a comprehensive way to examine risks arising during normal operation, fault conditions, and reasonably foreseeable misuse. However, terms such as “hazard,” “hazardous situation,” “harm,” “risk acceptability,” and “residual risk” are frequently misunderstood or applied inconsistently.

This practical webinar will explain the hazard-analysis process in clear, usable language. Attendees will be guided step by step through a hazard-analysis template, with examples showing how hazards develop into hazardous situations and potential harm, how risks are evaluated, and how appropriate controls are selected.

The program will also demonstrate how hazard analysis applies beyond product design. Attendees will learn how risk information should support supplier controls, validation activities, complaint and CAPA decisions, change assessments, and postmarket surveillance under the current QMSR environment.

Templates and step-by-step examples will be provided to help participants apply the concepts within their own quality systems and build risk decisions that are clear, consistent, traceable, and ready for regulatory review.

Areas covered in the session:

• Risk analysis requirements that are described in the QMSR
• explanation of Hazard Analysis terms: hazard, hazardous situation, harm, risk, acceptability criteria, benefit/ risk ratio
• explanation of the hazard analysis process using a template
• examples of terms will be given
• Application of risk management to Quality System processes will be explained
• hazard analysis examples will be covered step by step 

To support implementation of the concepts discussed during the webinar, attendees will receive the following handouts:

• Medical Device Hazard Analysis Builder and Worked Example
• QMSR Hazard Analysis Application and Update Decision Guide

Why should you attend?

Hazard Analysis is one of the most effective tools for identifying and controlling medical device risk, yet terms such as hazard, hazardous situation, harm, acceptability criteria, and benefit-risk are often misunderstood. This webinar will break down these concepts using clear explanations, practical examples, and a step-by-step template.

You will learn how Hazard Analysis applies beyond product design and supports important quality system decisions involving supplier controls, validation, complaints, CAPA, change control, and postmarket surveillance under the QMSR environment.

By attending, you will gain a practical framework for evaluating risk, documenting defensible decisions, and applying Hazard Analysis consistently across your quality processes. Templates and worked examples will help you put the concepts into use within your own organization.

Who Will Benefit?

This webinar is designed for medical device professionals responsible for identifying, evaluating, controlling, documenting, or reviewing product and quality-system risks. It will be especially valuable to those involved in supplier controls, validation, complaints, CAPA, change control, and postmarket surveillance; those include:

• Quality Assurance Managers
• Quality Systems Managers
• Regulatory Affairs Managers
• Risk Management Professionals
• Design Assurance Engineers
• Design and Development Engineers
• Research and Development Managers
• Medical Device Engineers
• Systems Engineers
• Software Quality Engineers
• Software Validation Professionals
• Human Factors and Usability Professionals
• Validation Managers and Engineers
• Supplier Quality Managers and Engineers
• Manufacturing Quality Managers
• Process Validation Engineers
• Complaint Handling Managers and Specialists
• CAPA Managers and Investigators
• Postmarket Surveillance Professionals
• Product Safety Professionals
• Clinical Affairs Professionals
• Internal Auditors
• Quality Compliance Specialists
• Regulatory Compliance Consultants
• Directors and Vice Presidents of Quality
• Directors and Vice Presidents of Regulatory Affairs