Profile

Thanks Mark this is very timely and helpful. Thanks for keeping us all up to date. ------------------------------ Mac McKeen, RAC RAC, MBA Fellow, Regulatory Science Maple Grove MN United States ------------------------------

It is being reported that the EUDAMED database implementation will be delayed up to 2 years.  For you EU MDR experts, does this have any impact on the May 26, 2020 MDR date? ------------------------------ Mac McKeen, RAC RAC, MBA Fellow, Regulatory Science Maple Grove MN United States ------ ...

Hi Lena, I will be there!   ------------------------------ Mac McKeen, RAC RAC, MBA Fellow, Regulatory Science Maple Grove MN United States ------------------------------

You can deliver the package/submission direct to the FDA receiving doc in Silver Spring, MD and have DCC receive your package and get a stamped confirmation. This will not be the acknowledgement email that is system generated but it will be issued the same day if you drop it off early in the morning.  ...

Dear Julie and Andrea, Thank you two for a delightful and thought provoking discussion.  No real discourse here as I believe we are all on the same page with respect to the CDRH initiatives and goals.   I was not at the meeting and no reference to failing in the slide deck so it must have been verbalized.  ...