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Bringing Metrology Into Medical Device Production

How metrology can bring the medical-device design and manufacturing process together

Photo by CDC on Unsplash

Mike John
Wed, 07/27/2022 - 12:01
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This article has been republished with permission from Medical Plastics News.

While ISO 13485 sets the standard for quality management systems (QMS) in medical device manufacturing, metrology is often treated as an afterthought and used simply to validate products and detect defects at the end of production. The result? It becomes harder to prove consistent quality, and the validation process can become fragmented.

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