Modern healthcare relies on connected medical devices, from infusion pumps and ventilators to wearable cardiac monitors. These devices deliver lifesaving functions, but can also introduce risk if they fail or become compromised. That is why continuous monitoring is a...
In the aviation, space, and defense (AS&D) industries, a single component failure can lead to catastrophic consequences. To mitigate these risks and ensure consistent quality, the International Aerospace Quality Group (IAQG) developed the AS9100 Quality...
In the aerospace industry, safety is non-negotiable. From passenger aircraft to defense systems, every airborne software component must meet rigorous standards. DO-178C serves as the benchmark for ensuring that aviation software is developed with the highest degree of...
Achieving ISO 26262 compliance can be difficult due to ever-changing technologies. Dive into this eBook to explore how your organization can ensure automotive compliance with the ISO 26262 standard.What You Will Learn This document provides guidance on the following...
Corrective and Preventive Action (CAPA) is a cornerstone of quality management in regulated industries. The CAPA process is essential not only for addressing current issues but also for proactively preventing future ones. It’s systematic, closed-loop, risk-based, and...
Unlock the secrets to seamless FDA compliance with our comprehensive eBook. This practical guide breaks down the regulations and standards that matter most, including 21 CFR Part 11 and Part 820, and walks you step-by-step through risk-based validation, robust...
Developing potentially life-saving products requires unparalleled performance, security, and compliance. However, as medical technology continues to evolve, so does the complexity of managing the systems that power it. Hospitals and healthcare providers are facing...
From my decades of experience in the IT and Engineering space, I’ve seen firsthand how even the most capable engineering teams can falter under the weight of compliance requirements. In highly regulated industries, the need to innovate quickly often clashes with the...
The value system and practices that embody Agile Software Development have been around for well over a decade, and have been touted as having "crossed the chasm" by organizations such as the Agile Alliance, Gartner, and Forrester Research. Numerous studies indicate...
In highly regulated industries like medical devices, maintaining data integrity and regulatory compliance is non-negotiable. One of the key regulations in this space is FDA 21 CFR Part 11, which governs the use of electronic records and electronic signatures. It...
The digital thread is a transformative approach to connecting data, systems, and teams across the product lifecycle. It enables seamless access to real-time data and traceability across departments and tools. However, for many organizations, implementing a robust...
Medical device manufacturing is one of the most regulated, complex, and high-stakes industries in the world. From ensuring compliance with evolving global regulations to protecting patient data, companies face a multitude of hurdles. These are just what is expected....