Vaccines are being rolled out across the globe. The process is occurring faster in some areas than others, sure, but the fact that a vaccine is being distributed at all means that the worst is behind us and that everything will go back to normal. Right?
Anyone involved in medical device manufacturing knows that their industry is highly regulated. Almost every medical device manufacturer or pharmaceutical supplier uses materials testing systems in their quality control and research laboratories or outsources their testing to approved third-party laboratories.
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.