As more and more software permeates products being released today, being able to update that software over time is an important part of the product lifecycle. In the case of medical device software updates, these are essential for keeping devices safe. From infusion...
ISO 9001:2015 is the internationally recognized standard for Quality Management Systems (QMS). It helps organizations consistently deliver quality products and services, meet customer expectations, and drive continual improvement. Achieving ISO 9001 certification...
Testing and calibration laboratories play a critical role in industries ranging from manufacturing and chemicals to healthcare and research. Their results often influence product safety, regulatory compliance, and customer trust. Organizations must ensure their...
In regulated engineering environments, maintaining compliance and managing quality controls are non-negotiable. However, navigating compliance documentation, procedures, and quality workflows can feel overwhelming for engineers. That is where Botable comes in. Botable...
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...