The Road to Better Traceability

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Many medical device development teams struggle with traceability, wasting hours, days, or even weeks creating and maintaining a traceability matrix. Other teams use integrated product development tools to more easily manage risk traceability and core artifacts.

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When created early in the product development lifecycle, a trace matrix can do more than just help you gain FDA approval for your device. Unfortunately, many companies create the matrix sporadically during a project, mainly right before regulatory submission—too late to capture the benefits a well-maintained matrix can deliver. During this recorded webinar, guest speaker Steve Rakitin, President of Software Quality Consulting, discussed five of the benefits gained by maintaining a matrix throughout the project. A software engineer with more than 20 years of experience in the medical device industry, Steve explains how a trace matrix can help you: - Plan and estimate testing and validation needs - Ensure all requirements are implemented - Verify that all requirements have been tested - Manage change throughout product development - Provide evidence that hazard mitigations are implemented and validated

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In this presentation, which was recorded at the 2013 Medical Devices Summit West in San Francisco, David Vogel of Intertech Engineering and Aimee Raymond of Cordis discuss some current problems and solutions in medical device development, including how to: - Manage the real hierarchy of harms, hazards, and causes - Prioritize and manage risk - Implement traceability to ensure risk controls have been implemented correctly - Deal with overall risk assessment and residual risk

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