Medical Device Hazard analysis following ISO 14971 - Understanding The Process in Detail in 2024

Overview:

In the world of medical device development, the US FDA places a high priority on risk management, expecting it to be an integral part of both the design control program and the post-production phase. Central to meeting these regulatory expectations is ISO 14971, a globally recognized standard that provides a comprehensive framework for managing risks associated with medical devices.

This webinar focuses on Hazard Analysis, a key component of ISO 14971. Unlike other methods such as FMEA and FTA, which mainly address fault conditions, Hazard Analysis is unique in that it considers risks under both normal and fault conditions, making it a more effective tool for ensuring product safety. Attendees will learn how to apply this technique to their own work, ensuring they can identify, evaluate, and mitigate risks comprehensively.

We will guide you through the detailed process of conducting a hazard analysis, breaking down complex terms such as “hazard,” “hazardous situation,” “harm,” “causative event,” “ALARP,” “risk index,” “benefit/risk ratio,” and “residual risk.” The session will use practical examples to illustrate these concepts, making it easier for you to understand and apply them in your work.

In addition to hazard analysis, the webinar will cover how to integrate these risk management practices into your overall design and development programs. This includes incorporating human factors studies to enhance safety and applying ISO 14971 principles to software risk management, which is increasingly important in today’s digital health landscape.

Areas covered in this session:

• Detailed process of conducting a hazard analysis
• The confusing terms “hazard”, hazardous situation”, “harm”, “causative event”, “ALARP”, “risk index”, “benefit/ risk ratio”, and “residual risk” will be explained
• We will go step by step through a template for risk analysis so that the process is clear
• Examples of hazards and hazardous situations will be discussed.
• How to deal with residual risk will be discussed.
• We will explain how to integrate Human Factors studies into the Hazard Analysis.
• How to integrate Hazard Analysis into the design program.
• Application of ISO 14971 principles to software risk management will be explained

Handouts:

Participants will receive the following handouts:

• Hazard analysis forms
• HA report template

Why you should attend?

Understanding and implementing effective risk management is crucial in the development and maintenance of medical devices. The US FDA and other global regulatory bodies expect manufacturers to adhere to ISO 14971, a comprehensive standard ensuring the safety and effectiveness of medical devices throughout their lifecycle. This webinar provides a detailed exploration of Hazard Analysis, a key element of ISO 14971, offering practical insights into identifying, evaluating, and mitigating risks effectively.

This session will clarify complex terms and concepts that often pose challenges in risk management, walking you through the process with practical examples to ensure a clear understanding. It also addresses the integration of hazard analysis into your design and development programs, including human factors and software risk management, which are critical in today’s digital health landscape.

Attending this webinar will ensure your risk management practices are robust, compliant, and up-to-date with the latest standards, thereby improving the safety and effectiveness of your medical devices. This session is particularly valuable for professionals involved in medical device development and regulatory affairs, providing essential tools and insights to enhance your expertise and ensure your devices meet the highest safety standards.

Who will benefit:

• Regulatory Affairs Specialist
• Quality Assurance Manager
• Medical Device Engineer
• Risk Management Specialist
• Product Development Manager
• Compliance Officer
• Clinical Affairs Manager
• Human Factors Engineer
• Software Validation Engineer
• Post-Market Surveillance Analyst
• Design Control Manager
• Quality Systems Auditor
• Project Manager for Medical Devices
• Safety and Compliance Engineer
• R&D Manager for Medical Devices