Regulatory Open Forum

 View Only
  • 1.  Post new Message

    Posted 24-Apr-2018 16:14

    There is literature on the RAPS website related to Canadian RAC preparation (Study Checklist/Exam content) that refers to EN1441.  Hasn't EN1441been superseded by ISO14971?

    This message has been marked as Medtronic Controlled

     

    [CONFIDENTIALITY AND PRIVACY NOTICE] Information transmitted by this email is proprietary to Medtronic and is intended for use only by the individual or entity to which it is addressed, and may contain information that is private, privileged, confidential or exempt from disclosure under applicable law. If you are not the intended recipient or it appears that this mail has been forwarded to you without proper authority, you are notified that any use or dissemination of this information in any manner is strictly prohibited. In such cases, please delete this mail from your records. To view this notice in other languages you can either select the following link or manually copy and paste the link into the address bar of a web browser: http://emaildisclaimer.medtronic.com


  • 2.  RE: Post new Message

    This message was posted by a user wishing to remain anonymous
    Posted 27-Apr-2018 09:00
    This message was posted by a user wishing to remain anonymous

    HC recognizes ISO 14971:2007. EN 1441 is obsolete both in the EU and in Canada. The link to HC standards website is below
    https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/standards-normes/md_rec_stand_im_norm_lst-eng.pdf


  • 3.  RE: Post new Message

    Posted 04-May-2018 10:08
    Hi,

    Thank you for pointing out this issue.

    It appears that that the reference to EN1441 was originally included as purely illustrative of the overall task, not as specific content. As such no question in any RAC exam includes any content related to EN1441. However, to make sure this is clarified I will ensure this reference is removed from literature on the RAC Canada.

    Regards,

    ------------------------------
    Pete Etchells
    RAC Manager
    Rockville MD
    United States
    ------------------------------