Community Event Week 2025: Exclusive Roundtables for Jama Connect® Users At Jama Software, we know the power of community. That’s why we’re thrilled to invite you to our Community Event Week, happening from May 12 to May 16! This exclusive event is just for our valued Jama Connect users, offering attendee-led sessions packed with insights, […]
Jama Software Provides a Single, All-in-One Solution for Requirements, Risk Management, and Validation Organizing requirements, managing risk, and ensuring validation are complex processes on their own. For teams in the medical device industry, these tasks are even more challenging due to stringent regulatory standards and the critical nature of the products themselves. Jama Connect®, a […]
Synopsys Bold Prediction: 50% of New HPC Chip Designs Will Be Multi-Die in 2025 Monolithic chips have been the workhorses behind decades of technological advancement. But just as the industrial revolution saw workhorses replaced with more efficient and powerful machinery, the semiconductor industry is on the cusp of a similar revolution. Multi-die and chiplet-based designs […]
Expert Perspectives: A Method to Assess Benefit-Risk More Objectively for Healthcare Applications Welcome to our Expert Perspectives Series, where we showcase insights from leading experts in complex product, systems, and software development. Covering industries from medical devices to aerospace and defense, we feature thought leaders who are shaping the future of their fields. In the […]
The Importance of Benefit-Risk Analysis in Medical Device Development Benefit-risk analysis is a crucial stage in the creation of medical devices. It entails evaluating the device’s possible benefits as well as drawbacks and deciding if the advantages outweigh the disadvantages. This examination aids in ensuring that medical devices are reliable, safe, and capable of being […]
Looking to stay ahead of ever-evolving regulations governing medical devices? In this webinar, we discuss the continual rollout of the EU Medical Device Regulation (MDR) and In-Vitro Device Regulation (IVDR) and the impact they’re having on the medical device industry. Vincent Balgos, Director of Medical Device Solutions at Jama Software and Saby Agai, Sr. Consultant […]
In this webinar, “Why it Makes Sense to Store Cybersecurity Risk Management Items Inside a Requirements Management System”, learn about the implementation of the Threat and Risk Analysis (TARA), the centerpiece of the new Automotive Cybersecurity standard ISO 21434. Many companies currently use spreadsheets to develop TARAs, which can be challenging when managing large sets […]
Trace Score™ – An Empirical Way to Reduce the Risk of Late Requirements Executive Summary One of the main causes of rework, delays, and cost overruns in product development is the creation of new requirements late in the process. This is a well-known risk in product development, but what management practices can empirically be shown […]
In this blog, we’ll recap our whitepaper, “Understanding Integrated Risk Management for Medical Devices” – To read the entire paper, click HERE. Understanding Integrated Risk Management for Medical Devices Knowledge on best practices, how to integrate risk-based thinking into product development cycles, and the importance of having end-to-end traceability to improve risk management, shared by […]
Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA Intro Over the years, the burden of Computer Systems Validation (CSV) has resulted in medical device manufacturers avoiding implementation of automated manufacturing production systems or upgrading long-outdated versions of software. As part of the FDA’s ‘Case for Quality’ initiative […]
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