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 challenge for innovators throughout the medical device development lifecycle. Constantly evolving regulations and the new complexities presented by connected devices makes management of these shifting complexities difficult. Our teams have been hard at work to bring this solution to fruition and help medical device developers simplify and accelerate the development lifecycle. This single platform can help accelerate innovation, maintain consistency and high product quality, and manage ever-changing complex regulations in medical device development.
“Developers are balancing increased regulatory requirements with device development costs that lead to challenges across the production lifecycle,” said Josh Turpen, Chief Product Officer at Jama Software. “We’re excited to introduce our new solution designed specifically for medical device companies which will help ease the development process from the start. Jama Connect allows developers to hit the ground running with preconfigured templates and best practices built-in, saving product teams from the cumbersome and often frustrating process of filing paperwork.”
Jama Connect for Medical Device Development can help teams:
• Easily demonstrate traceability
• Manage risk analysis
• Maintain audit trails and export data
• Improve product development with reuse and baseline management
• Streamline compliant reviews and approvals
• Manage design verification and validation
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 ISO 13485:2016, 21 CFR 820.30, and ISO 14971:2019, while applying a proven Systems Engineering approach to product development. When you purchase Jama Connect for Medical Device Development, our consultants partner with you to adapt the solution to fit your product delivery process and build adoption of Jama Connect within your organization. Contact us to learn more.
About Jama Software
Jama Software provides the leading platform for requirements, risk and test management. With Jama Connect for Medical Device Development, teams building complex products, systems and software improve cycle times, increase quality, reduce rework and minimize effort proving compliance. Representing the forefront of modern development, Jama’s growing customer base
of more than 600 organizations includes Boston Scientific, Johnson & Johnson, Abbott, and Merck.
Visit jamasoftware.com/solutions/medical-devices to learn more about Jama Software for Medical Device Development.