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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 […]
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? […]
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 […]
Medical devices have become increasingly complex, connected, and integrated systems. Yet many engineering teams still rely on documents and spreadsheets to manage development, risk assessments, and testing of devices to provide evidence of design control. This approach is no longer viable. Register to watch Axendia’s President Daniel R. Matlis and Jama Software’s VP of […]
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 […]
Last week, Jama Software launched Jama Connect® for Medical Device Development, which helps teams speed time-to-market without compromising quality or compliance. In our experience working with more than 200 medical device developers, we’ve realized how important it is to create best practices for risk management under ISO 14971, the FDA’s mandatory standard for risk assessment throughout the product development lifecycle. […]
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 […]
Editor’s Note: This post about moving beyond legacy systems for requirements management was originally published here on DevOps.com May 12, 2020, and was written by Josh Turpin, Chief Product Officer at Jama Software. We’re always proud to share great thought leadership and this informative post from one of our own is no exception! Getting Past […]
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 […]