Six months into an AI-assisted development push, a systems engineering team ran its first traceability audit. A significant share of the code generated by their AI coding agent had no traceable link back to any documented requirement. Test cases existed for features nobody had specified. Other features, ones the team had explicitly scoped, were missing […]
Accelerate Compliance and Requirements Review with AI Expert Recommendations at the Click of a Button Reviewing requirements and their associated compliance material is an essential component of developing a quality product. However, review time can often be consumed by arguing over the minutiae of syntax, grammar, and other secondary aspects of a requirement, rather than […]
As of today, we have completed the re-architecture of Jama Connect to AI-Native. This journey began two years ago, when we made the hard decision to re-architect to fully enable regulated, multidisciplinary engineering organizations to transition to AI-Driven Development. At the time, it was an aggressive decision given the level of investment, the uncertainty in […]
From Requirements to Test Coverage – Using AI to Strengthen Traceability and Validation Engineering teams frequently identify verification and validation gaps late in the development process — often during testing, audits, or certification reviews — when addressing them becomes both costly and disruptive. These challenges often stem from earlier stages, where unclear or inconsistent requirements […]
AI in Requirements Management: Where It Works, Where It Doesn’t, and What to Evaluate What if your team could spot ambiguous requirements the moment they’re written, keep trace links current without manual cross-referencing, and cut review cycles from weeks to days? That’s what AI brings to requirements management in 2026. Tools built on natural language […]
Augmented intelligence in medicine Artificial intelligence vs. augmented intelligence The AMA House of Delegates uses the term augmented intelligence (AI) as a conceptualization of artificial intelligence that focuses on AI’s assistive role, emphasizing that its design enhances human intelligence rather than replaces it. AMA policy on AI development, deployment and use The AMA is committed […]
Stop Scrambling for Submissions. Build Readiness Into Your Process With AI. Regulatory submissions often become a stressful, last-minute rush, increasing risk, rework, and frustration. But what if you could embed submission readiness into your process from the start? Artificial Intelligence (AI) is making this a reality by connecting requirements, regulatory guidance, and ongoing monitoring seamlessly […]
Navigating FDA AI Guidance for Medical Devices: A Practical Guide For medical device professionals, the integration of Artificial Intelligence (AI) and Machine Learning (ML) represents a monumental leap forward in innovation. However, this progress comes with significant regulatory hurdles. As AI algorithms evolve, so do the rules that govern them, leaving many development, quality, and […]
Transforming Requirements Engineering with AI to Enhance Clarity, Consistency, and Scalability As systems grow more complex, traditional processes struggle to keep up, ultimately impacting requirements quality. AI can assist in processing the sheer volume of data, enhancing clarity, consistency, and scalability across workflows. Join Katie Huckett, Product Line Manager for Advisor/AI at Jama Software, for an exclusive webinar exploring how AI is becoming an essential cognitive amplifier in requirements engineering. Discover […]
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