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Archive for October, 2013

Quality control rejected

The FDA red-list, what’s that?

Posted on October 29th, 2013 · Posted in Medical Device Manufacturing

Do you know for sure that your medical materials and parts suppliers are meeting FDA quality system regulations? One of the most common reasons medical manufactures are presented with 483s.. read more

FDA import hold 2

Help, my imported medical products are being held by US customs and the FDA. Now what?

Posted on October 16th, 2013 · Posted in Imported Medical Products

One of the most frustrating experiences for any importer is knowing that their products have arrived into the united states, but customs is holding the goods for inspection. This is.. read more

Image courtesy of sculpteo.com (printing the human body)

How will the FDA regulate 3D printing and rapid prototyping?

Posted on October 6th, 2013 · Posted in Medical Device Trends

As biotechnology continues to advance into the areas of cellular printing, it is becoming ever more difficult for the FDA to determine how these machines and the produced products will.. read more