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In Agile Development in Regulated Environments -- Part 1: Yes, it can work, I covered the common misconceptions about Agile Software Development -- specifically in highly-regulated industries like medical device. The common myth that regulators would not accept Agile...
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...
In the high-stakes world of aerospace engineering, failure is not an option. Whether developing spacecraft, military drones, or next-generation commercial aircraft, aerospace manufacturers must prioritize safety, reliability, and performance. One proven method for...
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...
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 the aerospace industry, every pound counts. As environmental regulations tighten and fuel costs remain a top concern, manufacturers are constantly seeking ways to improve aircraft performance. Many are implementing lightweighting and enhancing fuel efficiency to...
Tariffs have long been a tool of economic strategy, but recent escalations are impacting U.S. manufacturers, especially in the medical device industry. From 10% baseline tariffs to 245% duties on Chinese imports, companies now face inflated costs and disrupted global...
Designing and manufacturing aerospace products demands precision, innovation, and an unwavering commitment to safety. Engineers must balance complex assemblies and stringent regulatory standards while using lightweight materials. PTC Creo provides a comprehensive...
Today’s business environment requires companies to align with best-in-class vendors to be true, strategic partners. They need partners who understand their industry, their challenges, and their long-term goals. In the years we have partnered with our clients, some...
Ensuring avionics software is reliable and safe is a top priority for aviation engineers. However, maintaining compliance throughout the software lifecycle is no simple task. Utilizing an ALM tool such as PTC’s Codebeamer can help ensure compliance with aviation...