Medical devices can present unique challenges for manufacturers. Consequences for malfunctioning equipment can be dire. Because of this, medical device manufacturers must work hard to ensure that their products never fail.
Quality 4.0 derived from Industry 4.0, also known as the fourth industrial revolution. Prior to the fourth revolution, the first revolution started with machine manufacturing, steam power, and the move to cities by agriculturalists.
Quality is often misunderstood. More specifically, the benefits of a well implemented quality management system (QMS) are not universally known and appreciated, and that can cost lives. Conversely, when executives and manufacturing personnel understand the benefits of a QMS, patient outcomes improve, the quality of life is enhanced, and manufacturers prosper.
Medical device manufacturing poses unique challenges for maintaining quality and consistency. Medical devices must be built to exacting standards and their failure is simply not an option.
FDA regulated companies must establish quality systems for compliance. Most quality management systems (QMS) were developed to help comply with regulations with a sole focus on automating the paper-based processes around quality.