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  • 1.  RAC Device Exam - MDR

    Posted 14-Oct-2021 00:07
    Edited by Tara Creaven-Capasso 14-Oct-2021 00:08
    Hello fellow Reg Professionals:
    We are a small group in New Zealand preparing for the RAC Device exam intending to take the exam next month. One of the members has purchased the practice test in July from RAPS Resources, and we realise that the practice test questions and material is relevant to MDD and has not been updated yet to the new MDR/IVDR.
    Is there any one else preparing for the exam that has material and/or practice questions that you would be willing to share that test knowledge/application to the MDR and IVDR?
    Advice much appreciated to help with our prep.
    Thank you,
    Tara

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    Tara Creaven-Capasso, RAC, RQAP-GLP
    Founding Partner, Company Director
    Caduceus Medical Development, Ltd.
    New Zealand
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  • 2.  RE: RAC Device Exam - MDR

    Posted 15-Oct-2021 12:13
    Hi Tara,
    Although I haven't started the practice test yet, I was wondering this same thing when going through the EU Focus prep materials. The exam is based on regulations, standards, guidances in force as of December of the prior year (currently 2020). Because the MDR compliance deadline was extended to May 2021 and the IVDR compliance deadline is May 2022, I wonder if the exam even includes MDR/IVDR questions. Perhaps someone who took the Spring test, or someone at RAPS could answer.

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    Michael Thomas
    Regulatory Affairs Manager
    Salt Lake City UT
    United States
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    Original Message


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