In this post, we’ll explore how Jama Connect for Medical Device Development is designed to help you get ramped up quickly with a platform, training, and documentation aligned to industry regulations while applying a proven systems engineering approach to product development.
Read this blog to learn more about ten of the most prominent product development challenges engineers face and their corresponding solutions.
Infographic: Jama Connect™ for Medical Device Development We’re excited to share our latest infographic for the Jama Connect for Medical Device Development solution which explains how Jama Connect can help accelerate innovation, maintain product quality, and manage the ever-changing complex regulations in medical device development. This is a single powerful platform for medical device teams […]
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 […]
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 […]
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 […]
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 […]
Today, Jama Software announces a new solution: Jama Connect for Medical Device Development. The launch feels especially relevant right now. Over the next few weeks I’ll share details about it with you here in the blog. I’m going to talk about: The solution background: why it came to be and what it does. Solution Components […]
What Phases are Needed for Developing a Medical Device? Developing a medical device is an inherently complex process, and one that’s becoming more complicated all the time. In addition to the increasingly stringent regulatory requirements that must be met for FDA approval and/or EU MDR compliance, medical device manufacturers must also navigate ongoing changes […]
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