​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  If the MDD DofC goes away, the Australian DofC is no longer valid.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 ...

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 ------------------------------

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 ...