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Notable Changes in the new FDA Draft Guidance – Content of Premarket Submissions for Device Software Functions The FDA released its new draft guidance for the Content of Premarket Submissions for Device Software Functions on November 4, 2021.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 […]
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 […]
In this post, we highlight and summarize parts of the new “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Draft Guidance for Industry and Food and Drug Administration Staff.” It is important to note that this content contains non-binding guidance and therefore is not currently for implementation. With that said, while […]
> In this blog, we preview our whitepaper “FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?” Download the entire whitepaper to learn more! FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready? Technology innovation has undergone rapid transformation since the Food and Drug Administration first developed its […]
What Is “In Silico” and How Does It Benefit Medical Device Engineering? The medical device industry is a fast-paced world in which companies cannot afford to make missteps or fall behind. Med device developers who, in the past, have dominated the market are now faced with startups and tech companies entering the field. Innovations, such […]
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 Medical Device and Diagnostic Industry – Celebrating the 2022 Medical Design Excellence Awards Winners & Finalists […]
Editor’s Note: In this blog, guest author Rahul Varshneya – President of Arkenea – breaks down emerging technologies that are changing the way healthcare is delivered in 2022. Emerging Healthcare Technologies It’s apparent that the pandemic has hastened the healthcare industry’s digitization. Working hand-in-hand with technology is the future of healthcare, and healthcare professionals must […]
In this blog, we present a research report conducted by Axendia, a leading Life-Sciences Analyst firm, and presented by Jama Software, we walk through groundbreaking new research about the costly impact of ineffective requirements management in the medical device industry. Axendia Report: The Costly Impact of Ineffective Requirements Management Medical device organizations are continuing to […]
One of the early steps I advise my clients to take when developing their medical device is to determine the class and classifications of their medical device. In conjunction with the complexity of the device, understanding the class and classification sets the foundation for your product development timeline and effort. This post gives a basic […]
In this blog, we discuss key takeaways from a recent whitepaper, written by Ivan Ma, discussing Requirement Debt™. What is Requirement Debt™ Requirement Debt is defined as the gap between product requirements + requirement traceability and the perceived maturity of the program + product. How Reducing Requirement Debt Reduces Project Risk It is imperative that […]