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    RE: EU MDR Audit

    Hi, I am not able to understand when you say Quality audit, do you mean ISO 13485:2016 based QMS Audit? If yes, then it depends on your plan to transition to MDR. In case you have a plan to move to MDR before the audit (which is highly unlikely since your CE certificate expires in 2024), then they would expect your QMS to be compliant with MDR. Else ...

  • Hi,  We do Health Canada consulting work starting from $150 per hour to $250 per hour based on the type of work. Quality assurance & MDSAP work is on the lower side of the price and clinical evaluation & regulatory writing is on the higher side.  Please email me for more details and I will be able to assist you.  Regards, Kuldeep ------------------------------ ...

  • Hi, Oriel collects the all information regarding notification which the NBs like to share: https://www.orielstat.com/blog/eu-notified-bodies-designation-status-mdr-2017-745/ Hope this helps :-) ------------------------------ Britta Cyron Bochum Germany ------------------------------

  • Hi Yaara, I might be able to provide some assistance here. Feel free to contact me at josh.a.vanderiet@gmail.com. Thanks! Josh ------------------------------ Joshua Van De Riet Modi'in Israel ------------------------------

  • Posted in: RAC Community

    Hi everyone. My first post...Sorry, wrong community... ------------------------------ Yaara Auckland New Zealand ------------------------------

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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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