In this eBook, we examine the Systems Engineering Body of Knowledge (SEBok), provide an overview of the eight parts of the SEBoK, who should use it, and why it was created for systems engineering.
Learn about the new draft guidance for Premarket Submissions for Device Software Functions, the documentation levels, and the software documentation elements required for medical device development.
In this medical device research study from Axendia, a leading Life-Sciences Analyst firm, see how ineffective requirements management can negatively impact budgets, traceability, and V&V activities.
In this post, we pull out key takeaways from a recent whitepaper written in conjunction with Beanstock Ventures on the new EU medical device regulations (EU MDR) and how they might impact medical...
In the competitive world of medical device development, medical device companies can’t afford to lag behind other companies. Streamlining the design and approval process is vital to getting...
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...
54:38Join our webinar to learn more about how a good requirements management process helps facilitate compliance with FDA design control requirements.
Over the last decade, digital health solutions have become increasingly important, powering revolutionary developments in areas such as robotics, genomics, diagnostics, patient/provider...
44:12Join our workshop to see how Jama Software’s Companion MBSE solution can be used to eliminate common MBSE challenges and reduce barriers to broader adoption.
This post on Software as a Medical Device (SaMD) development is written by Mercedes Massana, the Principal Consultant of MDM Engineering Consultants. SaMD software is software intended to be used...
Machine Learning in Software as a Medical Device Machine learning (ML), a subset of artificial intelligence, has become integral across software in all industries, and the medical and life science...
Editor’s Note: This posts on EU MDR was originally published here by MedTech Drive and written by Greg Slabodkin. Dive Brief: While the Medical Device Regulation’s May 26 go-live date marks a...
Editor’s Note: This posts on lessons learned around medical device development during COVID 19 was originally published here by MedTech Intelligence and written by Josh Turpen, Jama Software’s...
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In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
In this post, experts explain why a keen focus on quality is the top trend for medical device development in 2021, and how teams can prepare.
In this post, subject matter experts from Jama Software and Beanstock Ventures discuss predictions for medical device product and systems development in 2021 and how they might impact the way your...
![[Webinar Recap] My Software Is a Medical Device (SaMD) – Now What?](https://content.cdntwrk.com/mediaproxy?url=https%3A%2F%2Fwww.jamasoftware.com%2Fmedia%2F2020%2F09%2F2020-09-01_BeanstockWebinarRecap_1024x512.jpg&size=1&version=1654707280&sig=425b5353e9023919a9f4c870fa86f89e&default=hubs%2Ftilebg-blogs.jpg)
In this webinar recap, we discuss the general medical device safety and performance principles of Software as a Medical Device (SaMD) development.
Based on our work with hundreds of medical device developers, we’ve compiled this guide to navigating the complexity of medical device compliance.
In this post, we'll explore how Jama Connect for Medical Device Development is designed to help you get ramped up quickly with a platform, training, and documentation aligned to industry...
Medical device manufacturers have a lot to keep track of these days. Between ongoing device development and preparing for the impending EU MDR, it’s more important than ever to maximize every...
