10 Biggest Product Development Challenges Engineers Face… And How to Solve Them
Read this blog to learn more about ten of the most prominent product development challenges engineers face and their corresponding solutions.
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Infographic: Jama Connect™ for Medical Device Development
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 […]
Part V: Using the Trace as a Way to Work
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 […]
What to Look for in Application Lifecycle Management Tools
Application lifecycle management (ALM) tools enable efficient, standardized communication and collaboration between teams in application development, testing, and other business departments. The benefits of a top ALM platforms include less risk from manual and siloed application lifecycle management processes, plus superior confidence in the outcome of compliance and product quality. What is application lifecycle management? […]
Part IV: Connecting Design Controls, Including Design Inputs, Design Outputs and Verifications
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
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
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 […]
Part One: Jama Connect™ for Medical Device Development Explained
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?
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 […]
Strategies for Remote Engineering Teams
Learn strategies and best practices to help your remote engineering teams collaborate successfully in their new remote work reality.