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 […]
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from HealthITSecurity – MDIC, HSCC Team Up to Establish Medical Device Security Benchmarks – which was originally […]
In this blog, we recap the “Understanding Integrated Risk Management for Medical Device” webinar. Companies involved in developing medical devices understand the importance of risk management, but their approaches can vary significantly in terms of the time it takes to manage risk, the ability to connect risks to specific requirements and tests, and the capacity […]
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