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.
Manufacturers and suppliers of emergency medical service (EMS) equipment are advised to check their products comply with IEC 60601-1-12: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment.
Machine vision technology has been in the market for years. However, with advances in technolo-gy and with the evolution of smart factory, the past decade has seen a drastic revolution in machine vi-sion equipment.
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.
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