For medical device manufacturers, having a product that functions as designed is critical, as a person’s health—or even their life—could be at risk. It’s one thing if my Alexa won’t respond to a voice command to remind me of a task, but it may be life threatening if my asthma inhaler won’t give me the medication I need when I’m struggling to breathe.
Medical technology advancements improve and sustain lives like never before. When a problem occurs with a medical device, actions to identify the root cause, correct the problem, and prevent it from happening again need to occur quickly. Having an effective corrective and preventive action (CAPA) process ensures timely resolution of issues.