Unfortunately the amount of differences between MDD and MDR compliance is quite significant much greater than can be listed on this thread.  CEN/TR 17223:2018 is helpful but it really only addresses Article 10 - there is much more to the MDR such as Annex I, II, III, XIV, articles on post market, etc.  We have developed a tool today stands around 100 ...

If you have less than 100 or so SKUs (bar codes, DIs) just use the web interface as Anne indicated since once set up does not take much to enter the data.  Definitely if you have less than 10 part numbers the web interface is the easiest.  In order to enter in the GUDID you need to wait until the 510(k) is cleared and maybe even a couple weeks until ...

I find it useful to look at some attributes to help understand this situation. They not always mutually exclusive.   Pre-market or post-market The dividing line is a complete DoC and CE Mark on the device. In Article 120 I take the dividing line as the NB audit to extend the device certificate.   QMS or Device Often there is a QMS requirement ...

Dear all, The post I shared about the study group was for Spring 2019, not for Fall 2019. Sorry about any misunderstanding! Wish everyone could pass the RAC exam! All the best, Shan ------Original Message------ ​Hi Shan,  thank you for organizing this. I would like to join.  My personal email is" patel67_4u@yahoo.com".  Nikhil patel ...

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