Medical Device & Life Sciences
Efficient requirements management with risk management allows your product development teams to focus on quality, safe, and secure medical devices and life sciences products
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The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know: Part 2
This is part 2 of a two-part blog series covering our whitepaper, “The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know” written by Vincent Balgos, Medial Solution Manager at Jama Software. In this paper, Vincent discusses the In Vitro Diagnostic Regulation (IVDR), developed by the EU Commission (CE), which […]
OSLC – What Is It and What Are Its Challenges?
What Is OSLC? OSLC (Open Services for Lifecycle Collaboration) is an “open” standard designed to facilitate communication between tooling primarily used in engineering disciplines. The initial work was done by IBM in 2009 and in 2013 governance moved to OASIS. The idea behind OSLC is to provide a common layer for tool vendors so that […]
Best Practices for Change Impact Analysis
Impact analysis is a key aspect of responsible requirements management. It provides an accurate understanding of the implications of a proposed change, which helps the teams make informed business decisions about which proposals to approve. The analysis examines the proposed change to identify components that might have to be created, modified, or discarded and to […]
European Regulatory Roundup, July 2022: Threat Of Ongoing Hurdles Masks Progress
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 Medtech Insight – European Regulatory Roundup, July 2022: Threat Of Ongoing Hurdles Masks Progress – which was […]
[GUIDE] ISO 13485 for Medical Device Development
In this blog, we introduce ISO 13485 and untangle everything your medical device development team needs to know about the important standard.
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Jama Connect® Features in Five: Basic Overview and Navigation
Jama Connect® Features in Five: Basic Overview and Navigation Learn how you can supercharge your systems development process! In this blog series, we’re pulling back the curtains to give you a look at a few of Jama Connect®’s powerful features… in under five minutes. In this Features in Five video, Carleda Wade, Senior Consultant at […]
The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know: Part 1
This is part 1 of a two-part blog series covering our whitepaper, “The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know” written by Vincent Balgos, Medial Solution Manager at Jama Software. In this paper, Vincent discusses the In Vitro Diagnostic Regulation (IVDR), developed by the EU Commission (CE), which […]
SITA Unveils eVISA and ETA to Transform Borders
Jama Software is always on the lookout for news on our customers that would benefit and inform our industry partners. As such, we’ve curated a series of customer spotlight articles that we found insightful. In this blog post, we share content, sourced from Times Aerospace, about one of our customers, SITA titled “SITA unveils […]