Compliance with environment, health, and safety (EHS) regulations is critical for organizations across fields. This is not just due to the importance of creating safe products, but also due to the financial benefits. The inability to compete in markets with...
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...
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...
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...
Hospitals depend on medical devices every day to deliver safe, accurate, and timely care. From imaging systems and surgical tools to specialized recording platforms, the reliability of this equipment directly impacts patient outcomes and operational efficiency. When...
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...
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...
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....
Product designs, documentation, and processes aren’t just valuable intellectual property, they’re your license to operate. In the highly regulated medical device industry, manufacturers must carefully consider these factors. If you’re using a Product Lifecycle...