Quality engineering must evolve faster than code; otherwise, agentic AI will move quickly, learn rapidly and fail expensively.

Quality management systems (QMS) have been in place since the beginning of the Industrial Revolution. They were used to manage and curtail defects in products and eventually evolved to become a set of ...

The present publication provides for the first time information and guidance for defining and implementing quality assurance programmes covering the entire life-cycle of software important to safety.

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...