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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 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 […]
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 […]
Today, Jama Software, introduced Jama Connect for Medical Device Development, a new solution designed to help engineering teams better manage device requirements, risk and design control all on one powerful platform. The newest release makes regulatory submissions and audit preparations a straightforward process, speeding time-to-market deployment with no reduction in quality. Consistent product quality and safety proves to be the top […]
Editor’s Note: In a time where remote collaboration and distributed teams are quickly becoming the norm rather than the exception, we’re proud to share this post on the value of effective collaboration around medical device design and product development. This article was originally published here on May 5th, 2020 by MedTech Intelligence and written by […]
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 […]
Building and then bringing a medical device to market as quickly as possible—all while preserving acceptable levels of quality and regulatory compliance—requires adept medical device risk management. By minimizing potential risks such as mislabeling and software-related issues, medical device manufacturers make each product safer for the patients who will use them. All of these risks […]