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    RE: CE Mark

    ​The TGA accepts the DofC you provided to your sponsor.  This is usually based on your EU DofC.  If the MDD DofC goes away, the Australian DofC is no longer valid.  Your agreement with your sponsor would require you to notify them.  It is up to your sponsor whether they will continue to market your products in Australia.  They are responsible to the ...

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    UOUP 62366-1:2015

    Is UOUP according to 62366-1:2015 applicable to UI developed using 62366-1:2007? Is it required to apply changes to the 2015 version to the old UI? ------------------------------ Manasi Mahajan RA/QA Engineer Burbank CA United States ------------------------------

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    Market advantage to CE marking to MDR now?

    This message was posted by a user wishing to remain anonymous ​​I've heard there are companies with Class I devices (not Is, Im, or Ir) that are CE marking their devices to the MDR now and using this as a market advantage. Assuming their QMS has been updated to follow MDR and the tech files comply with MDR, what would prevent a company from doing ...

  • ARUP is a great company and group of people to work with, from people I know! ------------------------------ Deric Glissmeyer Regional Director Salt Lake City UT United States ------------------------------

  • Hi RegEx Members, Are you interested in hearing about emerging risk management issues impacting healthcare products? Check out RAPS' first podcast! This newest quarterly release features Dr. Elaine Marrato, Associate Dean for Public Heather Practice and professor in Health Systems Management and Policy at the Colorado School of Public Health and ...

2018 Year in Review:
Highlights

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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