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
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
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
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
