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Jama Software is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from HealthITSecurity – MDIC, HSCC Team Up to Establish Medical Device Security Benchmarks – which was originally […]
What Is “In Silico” and How Does It Benefit Medical Device Engineering? The medical device industry is a fast-paced world in which companies cannot afford to make missteps or fall behind. Med device developers who, in the past, have dominated the market are now faced with startups and tech companies entering the field. Innovations, such […]
Editor’s Note: In this blog, guest author Rahul Varshneya – President of Arkenea – breaks down emerging technologies that are changing the way healthcare is delivered in 2022. Emerging Healthcare Technologies It’s apparent that the pandemic has hastened the healthcare industry’s digitization. Working hand-in-hand with technology is the future of healthcare, and healthcare professionals must […]
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 […]
Medical Device Risk Management Medical device developers must ensure risk is addressed as a core activity. The ISO 14971 standard, which has been revised three times, provides a proven and flexible framework around which developers can effectively manage the risk of devices for patients and stakeholders. Knowing the standard and applying some aspects, in a […]
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industry Requirements management solutions enable the unification of siloed processes and data that often reside in outdated, disparate, and disconnected legacy systems.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 […]
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 […]
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 […]
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, […]
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 […]