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I appreciate the EU commentary there Richard, because it just makes no sense to me.  It's 2022 - instead of "Where are the flying cars!?!", we're instead asking "Where are the approved eIFU pdfs?" (with paper backups, of course).  The vast majority of European clinicians have readily had access to internet ...

Hear!  Hear!​ ------------------------------ Reuben Lidster Regulatory Affairs Specialist Bloomington IN United States ------------------------------

Thanks Will, for sharing this RAPS Customer Service feedback.  I received the same.  I just went through this recertification process myself.  I agree, it is not the most straightforward process.  Wouldn't it be great, if the RAPS website that keeps track of the course credits we receive in one location, ...

Hello Hans, Thank you for your post.  I/we appreciate the information.  Above though you state, "EU Reg 207/2012 (eIFU for Medical Devices) might soon be expanded to also cover IVD devices."​  Yet do you know of any new plans to open up EU eIFU product labeling, beyond 'implantables and fixed installed ...

I worked for Apple for several years (in a field office capacity - only going to the Cupertino mothership for the annual Team meeting).  The company did get the needed clearances for its health related product features, and recognizes the Regulatory process and documentation required.​  Through apps ...