Agile methodologies: the early years In the early 2000s, the future of product development changed forever. Agile methodology originated in the software sector as a new approach to managing software development. Industry leaders knew they needed to find a new, innovative approach because many software development projects were failing or taking too much time to finish. A group of 17 software...

Getting new medical equipment on the market is only half the struggle in today’s regulatory environment, which is always evolving. Even when devices are released, more work still needs to be done, such as the beginning of post-market surveillance (PMS). The Importance of Post-Market Surveillance in Medical Device Manufacturing Manufacturers of medical devices must carry out post-market...

Today, many medical device companies are realizing the benefits of investing in an enterprise quality management system (eQMS) as they look to comply with stringent regulations and introduce safe, life-enhancing products to market. Yet oftentimes they are reluctant to make the leap due to employees’ aversion to change and comfort level with using manual or paper-based systems. We asked Arena...