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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industry Requirements management solutions enable the unification of siloed processes and data that often reside in outdated, disparate, and disconnected legacy systems.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 […]
Requirements Traceability – Does My Data Model Matter? Nearly all engineering organizations have one or more initiatives underway to improve their product development process. Live Traceability™, Model-Based Systems Engineering (MBSE), and digital engineering are the most common areas of focus. As engineers look over the fence and make fun of marketing types for being distracted […]
What is Digital Health? Digital health merges digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery to make medicine more personalized and precise. Digital health is a broad category that includes: Mobile health (mHealth) Health information technology (IT) Wearable devices Telehealth Telemedicine Personalized medicine Digital health technologies use: Computing […]
FDA Inspection Intro In Part One of this two-blog series, I shared 5 best practices to prepare your organization for FDA inspection success. Inspections by the FDA can lead to regulatory action and consequences such as warning letters, recalls, and consent decrees. Thus, you want to put your best foot forward to demonstrate the compliance […]
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 […]
Systems Engineers Career Path Most Systems Engineers we speak with have a common perspective on their role within their organization. Systems engineering as a concept is understood and supported by leadership. And, if systems engineering best practices are followed across all engineering disciplines, leadership also acknowledges the benefits the organization can realize. However, leadership will […]
In this post, we recap a recent webinar hosted by Jama Software on the topic of integrating TestRail and Jama Connect As the digital demands of the business continue to escalate, software delivery teams are under extraordinary pressure to deliver more work faster. Speed, however, counts for little if these teams are not delivering a […]
2022 Airborne Predictions 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 […]
This is Part 4 of a blog series covering a whitepaper titled, The Comprehensive Guide to Successfully Adopting Model-Based Systems Engineering MBSE. Visit Part I, Part II, and Part III. 04: Determine the Future State the Organization Needs to Be At The descriptions made previously for each of the ten areas of capability represent the level of capabilities […]
This is part one of a two-part series. Part two is available here. FDA Inspection FDA inspections can be daunting, especially for an organization that is expecting its first one. In part one of a two-blog series, here are five best practices to prepare your organization for success: 1: Understand why the FDA will perform […]