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Blog. Inside the Lines

easy hard

Our medical device is a low risk, class I product. Now our FDA process will be easy. Uh, oh…Think again!

Just because your medical device is considered “low risk” and “simple” doesn’t mean your regulatory process follows the same path. Did you know, some of the most frequent problems in.. read more

Quality control rejected

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

FDA import hold 2

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

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

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