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you reference the one you are compliant to.  However the deadline to switch to the 2016 version is coming soon.  Keep in mind as well if you are selling products in the EU and your Notified Body is a stickler for references you will want to reference EN ISO 13485.   In our documentation we don't reference ...

If you are interested please send me your resume, all experience levels will be considered. kdebarris@encision.com ------------------------------ Kathaleen DeBarris, RAC RAQA Analyst Boulder CO United States ------------------------------

Hello fellow Rappers, I am looking to do my first bundle 510k.  I've read the guidance document, however I was hoping for more so here I am.   For anyone that's done a Bundle 510k, or has experience with them, can you tell me some pros/cons, pitfalls, and mistakes to watch out for?   We believe ...

I'd be willing to attend. Can you email me the particulars?  My email address is kat.debarris@gmail.com Thank you ------------------------------ Kathaleen DeBarris, RAC RAQA Analyst Boulder CO United States ------------------------------

Hello, I would love it if our Colorado Group could meet up, perhaps sponsor some trainings and/or workshops.  I was in Chicago for training and happen to be in town when the Chicago RAPS chapter was having a training, so I attended.  It was great and they do it regularly.  I would be willing to help ...