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Hi all,  I'm looking for recommendations for ISO 13485 auditors. My client is in central Illinois. Thanks so much! Aimee ------------------------------ Aimee Feuser Trestlework, LLC Chicago, IL ------------------------------

Hi Virginia,  Great question. Thanks for bringing it up. This gets at the parts of Part 11 compliance that relies upon the associated control procedures surrounding the use of e-signature software (I included the applicable text from part 11 below). Basically, it is up to each company to have sufficient ...

Hi! I've run into this before and here's what I came up with: - For client/external signatures I use SignNow, which is super intuitive and user friendly. You can get three signatures per month for free. - For clients who need an affordable e-signature solution for their team (where there are often ...

Thanks so much, Ginger.  Is there risk that a Q-Sub that is based mostly around understanding the correct classification a pertinent requirements would get kicked by the FDA to a 513(g)? I feel weird initiating a Q-Sub when it seems like 513(g) is the appropriate mechanism, but it seems that many ...