EU Devices

Guest Editorial: Rebuttal to FDA’s Internal Report on EU Medical Device Regulation

July 24, 2012 | No comments

Guest Editorial from Robert Packard, Sr. Manager, Regulatory Affairs at Delcath Systems, Inc.: In February, at a press conference in Brussels, …

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EU Looks to Tighten Medical Device Safety With Implant Registry

April 30, 2012 | No comments

In the wake of high-level scandals in the EU, including the Poly Implant Prothese (PIP) breast implant snafu and the metal-on-metal hip …

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