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Congratulations! Your organization has gained regulatory approval and launched its medical device product. The ‘History’ in Design History File may elicit impressions that all those design and development requirements are now done and considered part of the past. However, several components of the DHF continue as a reference and evolve, including requirements and risk management. […]
As a medical device product development consultant, I often see start-up companies having trouble deciding what to prioritize – design controls and risk management or the quality management system (QMS). And what they mean specifically is, which software systems should the company invest in first – the requirements and risk management solution that will aid […]
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
In this post, we look at how Teledyne e2v leverages Jama Connect for improved communication and better risk management. Teledyne e2v is a global leader in specialized components and subsystems for innovative solutions in medical, science, aerospace, defense, and industrial applications. Over 1600 employees in countries across Europe, America, and Asia. As a result of their […]
Ultra Maritime UK Enlists Jama Connect for Naval Systems Requirements Management UK operation chooses Jama Connect for its ease-of-use and administration. About Ultra Maritime UK Founded in 1944 and acquired in 2021 by Advent International Over 2,300 employees across fifteen locations worldwide Premier provider of undersea warfare systems, products, and solutions to US, UK, Canada, […]
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 […]
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 […]
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 […]
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 […]