Risk Management Under ISO 14971

Why Should You Attend:

The risk file is one of the first things looked at when regulatory bodies conduct reviews for clearance to market. Errors or omissions in your risk file could lead to lengthy delays in the clearance process. The risk file is also closely examined during any postmarket inspection or review and especially when regulatory bodies investigate any adverse events. Responsibility goes straight to top management now and case history shows that falsifying information can lead to stiff penalties and jail time.

Every regulatory body is now laser-focused on ensuring medical devices are safe and effective. The “risk file” is now closely scrutinized multiple times in the clearance process and so organizing the information and providing in a clear manner is critical to ensuring a smooth path.

Participants will learn about setting corporate policy, establishing risk acceptability thresholds, building a risk management team, using the standard and its associated guidance document (TR 24971) to establish hazards and manage risks, considerations for demonstrating risk controls are implemented and effective, a method to approach overall benefit-risk analysis, and managing risk throughout the life of the product.

Areas Covered in the Webinar:

• Why compliance to 14971 is as much a good idea as it is required
• How to “think” in terms of risk management
• Corporate policy and responsibility related to risk management
• Considerations for the risk management participants
• Planning & Organizing
• Characterizing
• Conducting a Hazard Analysis
• Considering types of Risk Controls
• Conducting Risk Management
• Verification & Validation of Risk Controls
• Overall Benefit-Risk Analysis
• Production and Post market considerations

Who Will Benefit:

This webinar is intended for management, systems engineers, project managers and engineers of all disciplines who might be involved in risk management

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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