FDA's quality system regulation (QSR) details specific activities that mustoccur for a new medical device to be made and commercialized in theUnited States. QSR requirements govern “the methods used ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

The US Food and Drug Administration (FDA) is looking for some help from the medical device industry in the hopes of eventually creating a process of faster, more efficient and more predictable ...

Search for requirements management tools for medical device development and you’ll find plenty of content arguing that the established platforms are too heavy for modern teams. Much of it comes from ...

Device makers are taking increased interest in product designs and assembly that support closed-loop recycling. A Branson plastic welding process can safely and nondestructively “unweld” plastics used ...