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331Blog Post

[Webinar Recap] Lessons Learned for Reducing Risk in Product Development

In this blog, we will recap a webinar on reducing risk in product development Over the last 20 years, product development complexity has expanded exponentially, creating innovations in areas such as space tourism, autonomous vehicles, satellite communications, and more. In this webinar, Kemi Lewis, Senior Consultant at Jama Software, will demonstrate how Jama Connect© creates Live […]

332Blog Post

[Webinar Recap] The Real Intent of MBSE – Keeping Up with Complexity

In this blog, we recap a webinar discussing the real intent of MBSE (model-based system engineering.) Today’s products are becoming increasingly complex and software intensive. This presents major challenges for organizations being able to effectively manage all the data, information, and artifacts across the lifecycle for these types of systems — and one of the […]

334Blog Post

Understanding FDA Medical Device Class and Classifications, and its Impact on Requirements Management

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 […]

335Blog Post

Requirement Debt™: A Medical Product Program Risk

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 […]

336Blog Post

Why Your Medical Device Risk Management is NOT Effective

Medical Device Risk Management Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and flexible framework around which developers can effectively manage the risk of devices for patients and stakeholders. Knowing the standard and applying some aspects, in a […]

337Blog Post

[Webinar Recap] Why Word & Excel Are Not Enough to Manage Complex Requirements

In this blog post, we recap a webinar discussing why Word & Excel are not enough to manage complex requirements.  Product development is more complex today than ever before. Modern products are multifaceted and multidisciplinary, with hardware, software, and various engineering approaches coming together in the name of superior customer experience. Many industries — medical […]

338Blog Post

The Emergence of Technology for Insurance Product Development

This blog is part of a series written by Alan Demers, founder of InsurTech Consulting and author of Insurance Thought Leadership. For part one of this series, visit: The Top Challenges of Property & Casualty Insurance Product Development. Stay tuned in the coming months for more.   The Emergence of Technology for Insurance Product Development It […]

339Blog Post

Adopting MBSE: Challenging the Status Quo

  This blog contains excerpts from a whitepaper titled, The Comprehensive Guide to Successfully Adopting MBSE, written by Lou Wheatcraft.  Adopting MBSE: Challenging the Status Quo in Product Development For product development teams to successfully implement a practice such as model-based systems engineering (MBSE), it requires the willingness of an organization to perhaps change processes […]

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Requirements Traceability Alliance

Learn more about how the Requirements Traceability Alliance addresses the fundamental problem facing engineering teams – how to comply with Live Traceability requirements that must span siloed engineering disciplines using best-of-breed tools.