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[…] should be reviewed to understand the impact; impact to safety and effectiveness of the users, first and foremost, and also impact to the organization and business. For example, a manufacturer is notified by its supplier that a cooling fan is coming to its end of life and a different fan is suggested as the […]
[…] (d), late requirements contribute an additional 31% burden). Unsurprisingly, this additional burden of late requirements has an impact during testing for requirement validation. In our actual project examples, the Late Project has a test failure rate over 3x that of the Timely Project. RELATED: Unlocking The Power of Live Traceability with Jama Connect® Does […]
[…] Jira through our integration platform, Jama Connect Interchange™. As the Product Manager for Jama Connect Interchange (JCI), I often get asked by customers for best practices and examples of how to integrate Jama Connect with Jira, so their teams can collaborate across these tools more seamlessly. For the most part, the customers I talk […]
[…] so these are the topics that we’re going to cover. And without reading this slide, really we’re going to cover the development life cycle of creating, the example we’re going to use is a 48-volt power assist system. You might also think of it as a battery management system. And so I’ll go over […]
[…] the basic types of information that must be processed doesn’t capture the complexity of the details that have to be managed by the policy administration system. For example, while there is one set of requirements related to insured risk and coverages, there is an entirely different set of requirements for the output to describe […]
[…] can thrive for nearly 70 years without evolving its processes, and Finnish Red Cross Blood Service (FRCBS) is no exception. The FRCBS’s Vein-to-Vein project is a prime example of how the organization has evolved to meet the digital age in order to provide the best care possible for those in need. Jama Connect has […]
The US Food and Drug Administration (FDA) has issued new guidance that expands the Abbreviated 510(k) Program for medical device development and premarket notification submissions.
Improve collaboration, quality, and delivery in medical device development by freeing your teams from document-based design control and risk management.
[…] risk analysis, validations, traceability analysis, etc.) spread across hundreds of siloed tools, spreadsheets, emails, and chat tools with high degrees of uncertainty that any information reflects the latest version continually updated with all interdependencies. The main reason for this landscape of siloed tools is that each engineering discipline is empowered to choose a best-of-breed […]
[…] answers for safety are found in 4754A and 4761A; specifically, SAE’s ARP4754A and ARP4761A. In this whitepaper, written in conjunction with the avionics experts at AFuzion, we examine this important safety standard, and walk through: The foundation for ARP4761A and the safety assessment process Traceability as a system assessment process Common safety terminology Safety […]