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In this post, we recap a recent webinar hosted by Jama Software on the topic of requirements traceability. As the product and software development process grows in complexity, with more and more teams adding information, it is becoming increasingly difficult to track requirements throughout the development lifecycle and for stakeholders to get a clear view. […]
Are Legacy Development Tools Putting Your Development Process at Risk? The past few decades have ushered in a new way of working and now teams are expected to work more efficiently and collaboratively across the organization and supply chain. Companies building highly regulated and complex products often rely on legacy tools such as IBM® […]
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 […]
Award Winning Automotive Software Developer Selects Jama Connect® to Shorten Development Time, Increase Efficiency, and Sail Through Audit Preparation. Apex.AI, founded in 2017 in Palo Alto, California, is a mobility software company, and makers of the ISO 26262 ASIL-D safety-certified software framework Apex.OS. As a pioneer in modern C++ software development for safety, they are […]
Product development teams face many challenges in today’s fast-moving and increasingly regulated environment. Potential missteps, however, can create an expensive ripple effect throughout the product development cycle, with the potential for missed deadlines, compliance issues and more. Real-time collaboration and the need for a single source of truth are critical to product development teams. Outdated tools often don’t deliver on these needs, and a misalignment […]
In a previous post, Mario Maldari writes about his first week at Jama Software and gives insight into the Jama Software community and company culture. Version 1.0 – The beginning It’s hard to imagine that I started my career over 20 years ago, working on requirements management software. I had just moved out to Boulder, […]
Complying with FDA Design Control Requirements Using Requirements Management Principles Mercedes Massana: So agenda for today is we’re going to talk a little bit about the design controls and what they are. We’re going to talk about requirements management and what that is. And then we’re going to talk about how the two relate to […]
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. […]
In the competitive world of medical device development, medical device companies can’t afford to lag behind the pack. Streamlining the design and approval process is vital to getting products to market in a timely manner. Proper documentation is key to a smooth approval process. One essential ingredient to medical device documentation is the Design History […]