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  • Look at the new proposed Rule on intended use to see if this Guidance  will change about what a manufacturer has to do. I did not have time  yesterday to dive in. Has anyone? ------------------------------ Ginger Cantor, MBA, RAC Founder/Principal Consultant Centaur Consulting LLC River Falls, Wisconsin 54022 USA 715-307-1850 centaurconsultingllc@gmail.com ...

  • Hello, Theoretically if you use symbols from an internationally recognised standard like ISO 15223 according to the Annex I as Anne cited there should be no reason for translation.  But welcome to the real world.  First there is no harmonised standard and would not plan on any for a long time.  Second even the "updated" ISO 15223 has not been published ...

  • Hello William, Usually that type of training is acquired "on the job" when an employee works for a testing lab or central lab like LabCorp, or from an hospital, or other CLIA/CAP certified labs.  If you are looking for training for your internal employee there are a few options would be seeing if a certified lab does offer training on different types ...

  • Tier 1 $500k Tier 2 $100k See https://www.fda.gov/industry/fda-user-fee-programs/over-counter-monograph-user-fee-program-omufa Sent from my iPhone Sent from my iPhone

  • Anne and Leo, would you recommend the same if the software were a SaMD and the company supplied customers an android phone with the SaMD installed as an app? ------------------------------ Julie Omohundro, ex-RAC (US, GS), still an MBA Principal Consultant Class Three, LLC Mebane, North Carolina, USA 919-544-3366 (T) 434-964-1614 (C) julie@class3devices.com ...


Volunteer Appreciation 2020

As our members continue to strive for regulatory excellence, RAPS wants to provide the necessary membership benefits for them to do so. In an interview with some of our RAPS members, we asked them what membership benefits stood out to them the most. What benefits were their favorite? Because at RAPS your membership matters, and here, in RegEx, our community counts.

A special thank you to all our members who participated in this video. For those who would like to participate in future video interviews, please see the volunteer opportunity here

 

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