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Hi, It is probably not helpful to seek to find guidance documents to argue against your NB.  It's best to speak with them, and to seek to find a solution with them. Have you provided a root cause analysis for the current NC? Are you able to correct the NC immediately?  Do they have reasons ...

Well today, no EU AuthRep has experience in providing services under MDR. If you want a meaningful answer, you should also specify what is the nature of your product. Beyond the basic administrative support, the experience of the EU Auth Rep with your specific product is important.  Your notified ...

Dear Anjali, Your (software) product can have independent components or modules. But ultimately it has one intended use, one set of claims on what it does. When it comes to validating your product - confirming safety and performance, assessing risks, and possibly ensuring information security etc ...

Many thanks to the three of you, Ginger, Roger, and Lee, for taking the time to answer. It helps to have your confirmation ! Cheers -Ivan

Hi, I'm currently responsible for the submission of an FDA class II medical device, for a small EU company.  I've done this before as part of a larger organization, but in this new context I'd appreciate if a US-experienced peer could check a few assumptions: There are no User Fees for the ...