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81Blog Post

Innovative Dental Equipment and Technology Company, Convergent Dental, Selects Jama Connect® For Its Quick Adoption and Live Requirements Traceability

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In this blog, we partially recap this customer story, “Convergent Dental Selects Jama Connect,® For Its Live Requirements Traceability” Read the entire story HERE. In the medical device industry, proving that there are no unvalidated or unverified requirements is critical for compliance. While Convergent prepared to demonstrate compliance with De Novo Classification Request standards, they […]

82Blog Post

5 FBI Recommendations for Medical Device Cybersecurity

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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 Security – 5 FBI Recommendations for Medical Device Cybersecurity  – which was originally published on September […]

84Blog Post

Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA

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Incorporating Risk Traceability into Manufacturing Production Software and Preparing for the Transition from CSV to CSA Intro Over the years, the burden of Computer Systems Validation (CSV) has resulted in medical device manufacturers avoiding implementation of automated manufacturing production systems or upgrading long-outdated versions of software. As part of the FDA’s ‘Case for Quality’ initiative […]

85Blog Post

Jama Connect®: Accelerating Systems Development with Requirements Management and Live Traceability™

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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 Lifecycle Insights – Jama Connect®: Accelerating Systems Development with Requirements Management and Live Traceability™  – which […]

86Blog Post

The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know: Part 2

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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 […]

87Blog Post

OSLC – What Is It and What Are Its Challenges?

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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 […]

88Blog Post

European Regulatory Roundup, July 2022: Threat Of Ongoing Hurdles Masks Progress

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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 Medtech Insight – European Regulatory Roundup, July 2022: Threat Of Ongoing Hurdles Masks Progress  – which was […]

89Blog Post

The New EU In Vitro Diagnostic Regulation: What’s Changing and What You Need to Know: Part 1

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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 […]