Constructing a Benefit-Risk Analysis

Why Should You Attend:

Assessing the benefit – risk ratio is very much an inexact science. A true “weight” cannot be assigned nor can these be readily weighed against each other. Thus, many companies struggle with constructing the rationale for concluding the overall benefits outweigh the overall risks. Regulatory bodies are now taking a much closer look at the Benefit-Risk analysis and unsubstantiated claims that benefits outweigh risks are being rejected. A systematic approach to construct the rationale for such conclusions is needed.

The Benefit-Risk Analysis required by ISO 14971:2019 is a difficult concept. Neither benefits nor risks can be assigned “weight” so a systematic approach to constructing the benefit-risk analysis enables the analysis to provide the justification for claiming the overall benefits of a device outweigh the overall risks. The approach taken is aligned with guidance FDA uses when making risk-based decisions and with guidance. The approach will describe how benefits are characterized, how risks are characterized, and how these characterizations can be weighed against each other to establish a rational conclusion about the ratio.

Areas Covered in the Webinar:

• Background (ISO 14971 requirements)
• Participants
• Characterizing benefits
• Characterizing risks
• Heat maps
• Constructing conclusions
• Maintaining

Free Materials to the audience related to the topic

• Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions
• Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications
• MEDDEV 2.7/1 rev.4 - Clinical evaluation: Guide for manufacturers and notified bodies (ref A.7.2)
• Sample worksheet

Who Will Benefit:

This webinar is intended for medical device professionals engaged in conducting product risk analysis. The following roles are typically involved in constructing the benefit-risk analysis:

• Project managers
• R&D Quality
• Clinical personnel supporting risk management
• Management who gives final approval for conclusions
• Systems engineers

Don Hurd
VP Quality and Validation Services , The Realtime Group

Don Hurd has over 35 years of experience in supporting development of applications of or containing software in regulated industries, the last 17 in medical devices. With his diverse background, Mr. Hurd provides a unique insight into driving product quality and ensuring high productivity of development organizations. Mr. Hurd is currently the Vice President of Quality and Validation Services for The Realtime Group, a contract R&D firm specialized in serving the regulated industries, primarily medical devices. In this role, Mr. Hurd led the company to certification in both ISO 9001 and ISO 13485, maintaining certification for nearly 15 years. In his role at Realtime, Mr. Hurd supports clients in efforts ranging from Quality Management System development, deployment, and remediation; product and development quality planning; verification and validation of products, product software, and non-product software; supplier qualification, approval, and management; transitioning product from development to manufacturing; supporting post-market vigilance / surveillance; and interfacing with ISO auditors and FDA inspectors. Mr. Hurd has been an ASQ Certified Quality Auditor since 2009. Mr. Hurd is active in the ASQ Biomedical Division Discussion Group, ASQ Audit Special Interest Group, and bionorthTX, holding leadership positions in each.

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