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When dealing with medical problems, the medical device should not add to these problems. Medical device manufacturing requires the highest quality—and industry takes no chances with this. Regulations are de rigueur. The need for quality of a bone screw should be obvious, and the same goes for any medical device.

For medical parts manufacturers, quality inspection is critical. Liability for defects, inconsistent quality, fluctuating supplier costs, increased globalization and device regulations all pose challenges for the industry.

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 product manufacturers—including producers of medical devices and plastic medical components—are in the some of the most competitive segments of manufacturing. And many of them are growing 10% a year or faster than their peers, according to a recent survey of 151 North American manufacturers conducted by research firm Decision Analyst on behalf of IQMS.