Articles by Sai Ranjith Ramakrishnan Kumar

When people think of medical devices, they often picture pacemakers, insulin pumps, or MRI scanners. Increasingly, however, medical innovation no longer comes in metal or plastic—it comes in code. Software as a Medical Device (SaMD) refers to software intended to perform a medical function without being part of a physical device.

The medical device industry is evolving with AI and automation affecting production and quality management. Quality engineers are moving towards systems thinking and proactive decision-making, as AI becomes integral to production, presenting challenges and opportunities for innovation while ensuring safety.