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11Blog Post

G2 Names Jama Connect® the Leader in Requirements Management Software in their Spring 2022 Grid® Report

G2 Names Jama Connect® the Leader in Requirements Management Software in their Spring 2022 Grid® Report Thank You to Our Customers Jama Connect® was again named the overall leader in the Spring 2022 G2 Grid® Report for Requirements Management Software! In addition to the honor of being named the only leader in requirements management software, we are […]

12Blog 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 […]

13Blog 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 […]

14Blog Post

[Webinar Recap] The Costly Impact of Ineffective Requirements Management in the Medical Device Industry

In this post, we recap a recent webinar hosted by Jama Software on the topic of requirements management in the medical device industry Requirements management solutions enable the unification of siloed processes and data that often reside in outdated, disparate, and disconnected legacy systems. However ineffective and inefficient, the industry still relies overwhelmingly on static […]

15Blog Post

2022 Predictions for Medical Device Development: Increased Focus On Cybersecurity, Clarity On Standard Compliance, and the Challenge of Human Variability

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 […]

16Blog Post

Requirements Management Planning: A Guide for Product Teams

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 […]

19Blog Post

Suspicious Requirements: The Importance of Suspect Tracking in Requirements Management

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 […]