By Zeb Geary

Part V: Using the Trace as a Way to Work

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In the previous Jama Connect™ for Medical Device Development solution post, we learned how Jama Connect could: Establish and manage trace between design inputs and design outputs. Establish and manage trace between design inputs and verifications. Provide insight across these related Design Control activities. Specifically, we saw how trace helped ensure alignment of these controls through acceptance criteria, increasing confidence in our verification activities and supporting visibility into the conformance of design outputs. Capturing and managing design […]

Part IV: Connecting Design Controls, Including Design Inputs, Design Outputs and Verifications 

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In the previous blog of this series, we talked about the application of systems engineering principles to the design inputs process. In this post, we explore how the Jama Connect™ for Medical Device Development procedure guide describes connecting design inputs with subsequent processes: Design Outputs and Verifications. By supporting these processes in a single system and […]

Part III: Design Inputs in Jama Connect for Medical Device Development 

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As medical device manufacturers develop complex products, they require a product development approach capable of managing that complexity.    At the same time, manufacturers must continue to ensure compliance and alignment with regulations and standards. These define requirements that ensure safety and quality and reduce risk—but ultimately do not prescribe specific tools or techniques.   This is especially apparent in design control activities. Regulatory requirements define the “what” for compliance but leave the “how” to the manufacturer, as long the procedures describing […]

Part II: Solution Components of Jama Connect for Medical Device Development

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Solution components in the Jama Connect for Medical Device Development solution help teams reduce time-to-value, provide guidance around customer-specific needs, and drive adoption. We wanted the solution to offer a collection of training and documentation components that aligns to industry regulations so product development teams could get ramped up quickly. The result: an out-of-the-box configuration of Jama […]

Why Systems Thinking Improves Medical Device Development

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Systems thinking is an approach to solving complex problems by breaking their complexity down into manageable units so the system can be evaluated holistically and by each constituent part. In our experience working with some of the market’s foremost medical innovators, we’ve seen that teams who embrace systems thinking are better-positioned to modernize and improve their product development processes.