Medical Device Development with Jama Connect Part 1: Traceability and Requirements-Based Design

Описание: In this insightful interview we discuss the importance of traceability and requirements-based design in medical device development with DornerWorks Technology Strategy Leader for Medical Devices, Dan Rittersdorf, and embedded engineer, Nate Bowen. They shed light on the challenges faced when relying on manual documentation methods such as Word documents and spreadsheets for requirements management and test coverage. The potential risks associated with a lack of traceability in the development process of medical devices, including the risk of rejection by regulatory bodies like the FDA, are also explored.

The interview delves into the game-changing capabilities of Jama Connect, a requirements management tool that serves as a single source of truth for all project documentation. The tool's bi-directional tracing, comprehensive test coverage analysis, and integrated commenting and collaboration features are highlighted, allowing development teams to ensure that every requirement is verified and linked to the corresponding test cases. This seamless integration results in significant cost savings as developers can run specific subsets of tests instead of the entire suite, making post-change verification more efficient.

Furthermore, Dan and Nate emphasize the support provided by Jama Connect in meeting process requirements around medical device development, such as ISO 62304 for software and risk management. By using Jama Connect, medical device development teams can easily approach regulatory compliance and documentation requirements in the industry. The tool enables complete traceability, from requirements to tests, risk management, and design files, ensuring that all aspects of the product are thoroughly covered and interrelated.

Don't miss this opportunity to gain valuable insights into the world of medical device development and how Jama Connect can revolutionize the way you manage requirements and ensure regulatory compliance.

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