The FDA red-list, what’s that?
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
Clear direction in today’s regulatory and manufacturing landscape
Archive for October, 2013
Help, my imported medical products are being held by US customs and the FDA. Now what?
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
How will the FDA regulate 3D printing and rapid prototyping?
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
