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3 Lessons Learned From EU MDR Implementation To Ensure IVDR Adoption In the previous article, “How The Right Operating Model For EU MDR Compliance Can Support A Global Footprint,” we discussed key factors for maintaining operational excellence to achieve cost reduction, enhanced compliance, and support global footprint. In this article, we shift our focus toward […]
Mastering ISO/IEC 27001: A Guide to Information Security Management Understanding Information Security Management Information security, often referred to as cybersecurity, is a critical aspect of modern technology and business operations. It encompasses the protection of sensitive data, systems, and networks from unauthorized access, disclosure, disruption, modification, or destruction. The evolution of information security practices has […]
Best Practices for Live Requirements Traceability As the product and software development process grows in complexity, with more and more teams adding information, it is becoming increasingly difficult to track requirements throughout the development lifecycle and for stakeholders to get a clear view. Every decision can have an impact on the requirement or the product […]
FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests Today, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns […]
Jama Connect® Recognized as a Top Rated Requirements Management Solution on TrustRadius! Jama Connect® has achieved notable recognition on TrustRadius, solidifying its position as a leading platform for requirements, risk, and test management. With an intuitive user interface, robust features, and exceptional customer support, Jama Connect has been honored with a “Top Rated” distinction by […]
What You Need to Know: ANSI/AAMI SW96:2023 — Medical Device Security Managing risk around a medical device’s entire lifecycle has become increasingly complex. Many devices use third-party components, which is especially true for devices that require a network to operate. This increased need for connectivity, along with other emerging threats, is putting security at the […]
Ramping Up Security to Meet Operational Resilience Rules Philip Pearson, Field Chief Information Security Officer at Aqua Security, discusses how meeting operational resilience targets is crucial for effective cybersecurity measures. Operational resilience is the ability to prevent, withstand, recover, adapt and learn in the face of disruption, including cyber events. Currently, it represents a far-reaching […]
G2® Once Again Names Jama Connect® the Overall Leader for Requirements Management Software for Spring 2024 In the competitive landscape of requirements management solutions, Jama Connect® has once again emerged as the overall leader in the Spring 2024 G2 Grid® Report for Requirements Management Software. G2 rates products and sellers based on reviews gathered from […]
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 […]