Overview: GRP’s whitepapers provides an overview of international guidelines for Software classified as a Medical Device. What is Software as a Medical Device? International Medical

Overview The FDA Breakthrough Devices Program is a voluntary program that can be used by manufacturers of medical devices, and certain combination products, that provide

OVERVIEW A pre-approval inspection (PAI) is performed to contribute to FDA’s assurance that a manufacturing establishment named in a drug application is capable of manufacturing

Overview: A 510(K) is a pre-market submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective

OVERVIEW: The FDA requires any foreign establishment to appoint a United States agent ( U.S. agent ) for that establishment.  Download the White Paper Contact

Overview : Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), including those