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This is Part 2 of a blog series covering a whitepaper titled,The Comprehensive Guide to Successfully Adopting Model-Based Systems Engineering MBSE. Visit these links for the rest of this series: Part I, Part III, and Part IV. Adopting MBSE What does it mean to practice SE from a data-centric perspective? Successfully adopting MBSE and moving toward a […]
In many ways 2021 was a continuation of the changes brought about in 2020, a year that’s been described as “unprecedented” and “unparalleled.” In a unique way, 2021 has offered us an idea of evolving innovations and technology on the horizon for teams across industries. These changing conditions will present a variety of new landscapes and will offer unique challenges, opportunities, and more than likely, many surprises. As we enter a new year of further […]
This is Part I of a blog series covering a whitepaper titled, The Comprehensive Guide to Successfully Adopting Model-Based Systems Engineering MBSE. Visit these links for the rest of this series: Part II, Part III, and Part IV. Introduction In a previous paper, we discussed key questions concerning Model-based Systems Engineering (MBSE) including what MBSE is, […]
In this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical device development. As medical device technologies have rapidly advanced in recent years, regulations governing definitions, testing, and post-market activities have struggled to […]
Requirements Management Plan Product success depends upon the successful project management of the product’s requirements. Effective requirements management, in turn, requires thoughtful planning. A requirements management plan describes how you will gather, analyze, document and manage the requirements of the project. It should describe how you intend to gather the high-level project and product requirements from project stakeholders, industry standards and governmental regulations, as well as the more detailed product requirements you will collect and […]
In the quest for a successful product development process, there are any number of steps that could go wrong or lead to release delays or cost overruns. Few, however, are as vital to a good outcome as the requirements gathering process. The requirements gathering process is central to a timely and efficient release of a […]
This is Part 2 of a series examining the role legacy requirements management solutions, such as IBM® DOORS®, play in introducing project risk to the product development process. To read Part 1, visit Why Migrate, Why Now?: Part 1 5 Common Migration Myths Debunked Transitioning to a new solution doesn’t have to be challenging; however, […]
Impact and change Analysis are two important concepts in requirements management. Understanding how a change made to one requirement, impacts the upstream and downstream relationships is essential in assessing the scope a change may make. What happens when a change IS made to an upstream requirement, and you are a downstream stakeholder? How will you know […]
Design review processes and their impact on product development. Development organizations typically have a predefined set of formal design reviews that are held throughout the development process. A design review usually includes assessing design input requirements for adequacy, assessing the adequacy of a design to fulfill design input requirements, and verification/validation-related reviews. When done correctly, […]
The complexity of products is rapidly growing, and as a result, the number of requirements needed to satisfy client goals is also expanding. This makes the documentation process time-consuming and potentially risky. Existing approaches to Requirements Management (RM) aren’t always flexible enough to meet stringent expectations and provide a single source of truth. Everyone involved with a project requires maximum visibility to understand what […]