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Impact analysis is a key aspect of responsible requirements management. It provides an accurate understanding of the implications of a proposed change, which helps the teams make informed business decisions about which proposals to approve. The analysis examines the proposed change to identify components that might have to be created, modified, or discarded and 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 […]
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. […]
magniX chooses Jama Connect for its ease of use, quick deployment, and to help modernize their requirements management program and demonstrate compliance with standards. Headquartered in Everett, Washington – located just outside of Seattle – magniX is the leading developer of propulsion systems for electric aircraft, including motors, inverters, and motor controllers. magniX is working to […]
As a medical device product development consultant, I often see start-up companies having trouble deciding what to prioritize – design controls and risk management or the quality management system (QMS). And what they mean specifically is, which software systems should the company invest in first – the requirements and risk management solution that will aid […]
In this post, we look at non-functional requirements are tracked by agile product teams and how they impact the product development cycle. Imagine that you’re in the market for a new car. As you shop, you have a couple of non-negotiable features or attributes in mind, such as saving destinations within the car’s built-in GPS […]
EDITOR’S NOTE: This post on requirements was originally published here, by Medium, and this article was adapted from Software Requirements, Third Edition, by Karl Wiegers and Joy Beatty. If you’re interested in software requirements management, business analysis, project management, software quality, or consulting, Process Impact provides numerous useful publications, downloads, and other resources. Creating a Culture that […]
How to Choose the Right Tool for ASIL D Requirement Management ISO 26262 / IEC 61508 Editor’s Note: This posts on tool selection around ASIL D requirement management for ISO 26262 / IEC 61508 was originally published here by LHP Engineering Solutions and written by Steve Neemeh. When the options for choosing a requirements management […]
Jama Software has partnered with Karl Wiegers to develop this 3 part blog series where he discusses techniques for defining project scope.