In this blog, we’ll recap our whitepaper, “When Evaluating Product Development Software Tools, Not All Cloud is Equal” – To download the entire whitepaper, click HERE. When Evaluating Product Development Software Tools, Not All Cloud is Equal As product development has become increasingly complex to manage across siloed teams and tools, the need for organizations […]
This is part 2 of a two-part blog series covering our whitepaper, “The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know” written by Vincent Balgos, Medial Solution Manager at Jama Software. In this paper, Vincent discusses the In Vitro Diagnostic Regulation (IVDR), developed by the EU Commission (CE), which […]
This is part 1 of a two-part blog series covering our whitepaper, “The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know” written by Vincent Balgos, Medial Solution Manager at Jama Software. In this paper, Vincent discusses the In Vitro Diagnostic Regulation (IVDR), developed by the EU Commission (CE), which […]
In this blog, we recap the “Driving Business Outcomes with Jama Software’s Success Programs” webinar. When you buy Jama Connect, you’re not just buying the #1 requirements management solution on the market. Our Customer Success team stands behind you, delivering the expertise, guidance, and resources you need to see a quick return on your investment […]
In this blog, we recap the “Implementing Requirements Management for ISO 21434” webinar. As the automotive industry becomes more complex and more connected, cybersecurity is emerging as a major concern, and therefore priority, for development teams. According to Juniper Research, there are 206 million cars on the road with embedded connectivity and by 2025, the […]
Best Practices for Efficient and Compliant Risk Traceability from Design to Manufacturing Intro Those familiar with medical device development know that risk traceability and risk management is an important aspect that threads through the entire product development process and lifecycle. Many see risk management as discrete deliverables completed by different team members at certain phases […]
In the rush to build a product, it’s important to establish boundaries for each team while also working as a unit, and develop processes to head off trouble before it begins.
Notable Changes in the new FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions The FDA released its new draft guidance for the Content of Premarket Submissions for Device Software Functions on November 4, 2021. Once approved, this guidance will replace the preexisting Guidance for the Content of Premarket Submissions for Software […]
What is the Urgency Behind Automotive Cybersecurity? From a Market Perspective: As automobiles are growing increasingly connected, digitized, and complex, automotive cybersecurity has become top of mind. Made up of hundreds of “tiny computers” – each with its own networks and servers – a singular vehicle is open to millions of opportunities for cyber-attack. In […]
Design Transfer: Best Practices for Translating Your Device Design into Manufacturing Specifications Manufacturing specifications are successful when they result in your medical device being produced consistently, over and over, and meet requirements and expectations, including those of design intent and quality specifications. In this blog post, I’ll share the best practices I follow when translating […]
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