As it turns out, replacing humans is no simple task—just ask anyone in the robotics field. Robots designed to do relatively simple tasks like taking inventory in a supermarket are incredibly complex, involving thousands or tens of thousands of electrical and mechanical parts, as well as software components. In addition to complexity and volume, many parts for robots rely on custom designs that...

Quality teams often think of their role as different and separate from product development. However, in today’s increasingly complex medical device market, a product-centric approach to quality management is fundamental to delivering high-quality devices. Next-level proactive quality management processes require a closer connection between product development and quality teams to address...

Why the need to validate? In the journey to deliver safe and effective devices to market, medical device manufacturers must simultaneously manage a myriad of regulations. To maintain quality compliance throughout the manufacturing process, quality leaders have the option to use various types of quality management systems (QMS). They can leverage manual, paper-based ones; on-premises software; or...