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I think this first begs the question how many product codes are associated with the 510k?  While occasionally there are two, in most cases there is just one.  Why is the original product code no longer appropriate, especially if you are narrowing indications within the intended use associated with the ...

Ha.  For a second I thought I had made it to the end to see perusal of said regulatory text when I got to the picture of Junior laying with his butt on a magazine!  Great pictures @Joanne Won​ ------------------------------ Michelle Lott RAC Principal & Founder michelle@leanraqa.com --------- ...

Hello - thank you Corey and those who messaged me privately for interest in attending the webinar.  RAPS opened it for registration recently.  Please register here to participate https://bit.ly/3CeIqiT I look forward to see you all there! Thanks @Ryan Connors for setting it up! Still not too late ...

Hello, I have used Essenvia (www.essenvia.com) to create and manage US and EU submission and documents.  It is an extremely efficient way to build submissions minimizing the redundancy of information and sharing information and documents across submissions. ------------------------------ Michelle ...

RAPS is in the process of setting up the registration for this event.  I will post the details on this string when it becomes available.  Stay tuned! ------------------------------ Michelle Lott RAC Principal & Founder michelle@leanraqa.com ------------------------------