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FDA Outlines its Approach to Artificial Intelligence Regulation “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development. U.S. regulation of artificial intelligence (AI) in medical devices will involve cooperative work […]
Manage by Exception: Data-Driven Practices to Improve Product, Systems, and Software Quality Requirement errors in product development cost time and money and create potential liabilities. The expense of these errors can make up between 70% and 85% of all rework costs. When leaders don’t have data related to the execution process, teams aren’t tracing requirements […]
Understanding ISO/IEC 27001: A Guide to Information Security Management In today’s interconnected world, the importance of securing sensitive information cannot be overstated. Organizations face numerous threats to their information assets, ranging from cyberattacks to data breaches. To address these challenges, many businesses turn to internationally recognized standards for information security management, with ISO/IEC 27001 standing […]
Jama Connect® Features in Five: Automated Testing 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 the powerful features in Jama Connect®… in about five minutes. In this Features in Five Integration Series video, Steven Pink – […]
Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification Since the introduction of the EU MDR in 2017, the medical device industry has learned just how challenging obtaining initial MDR certification truly is. According to a survey of notified bodies, the number of certificates issued as of June 2023 covers roughly one-third of the […]
Best Practices for Writing Requirements “Needs.” “Features.” “Requirements.” Regardless of what terminology your teams use to identify and define requirements, the purpose of good requirements is to create a shared understanding of the promise, functionality, appearance, and value for the products you develop across all stakeholders. In this insightful session, our industry experts will guide […]
Applications of Systems Engineering in Healthcare When it comes to healthcare, time to market is one of the most crucial aspects of success or failure. However, medical product development teams face several challenges that slow product development, and in the quest to speed up the process, some teams are turning to systems engineering to improve […]
Cybersecurity Concerns for Manufacturers in 2024 The more networked and data-centric manufacturing becomes, the more manufacturing leaders ought not consider cybersecurity as something that only concerns the IT department. New SEC reporting rules and high-profile hacks against manufacturers with multimillion-dollar price tags last year curtly demonstrate the point. Org-wide planning provides the best defense against […]