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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 […]
This is Part 3 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 II, and Part IV. Developing a roadmap to successfully adopting MBSE within your organization In this section, we provide a general approach or roadmap […]
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 […]
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, […]
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 […]
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 success of a development project relies on understanding the business need and defining the correct list of requirements. Requirement elicitation is the process of communicating and collaborating with key stakeholders to assemble the insight and identify the project’s needs. This article will provide an overview of why requirements elicitation is important for product […]
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. […]