Regulatory Open Forum

Hi all,
I am considering purchasing the new 2017 edition of RAPS' Fundamentals of EU Regulatory Affairs for my team, but was hoping to get some reviews from people who have already purchased it. I know it includes the new EU MDR requirements, which is what I am looking for, but does it go into some good detail or does it ust paraphrase the MDR? 

Given that they are revised every two years, are there enough significant changes (besides the obvious MDR ones) to warrant purchasing this edition over the last one?

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Lena Cordie
Qualitas Professional Services, LLC
Victoria MN
United States
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I, too, am interested in everyone's opinion.  Does this book provide sufficient guidance on IVDs.  It seems like many documents and training for the new EU regulations really skimp or almost outright ignore the IVD side of medical devices.  Does this book warrant its price for IVDs?

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Joy Pelfrey
Director of RA/QA
Norman OK
United States
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Original Message:
Sent: 12-Dec-2017 14:35
From: Lena Cordie
Subject: RAPS EU Fundamentals - Latest Edition

Hi all,
I am considering purchasing the new 2017 edition of RAPS' Fundamentals of EU Regulatory Affairs for my team, but was hoping to get some reviews from people who have already purchased it. I know it includes the new EU MDR requirements, which is what I am looking for, but does it go into some good detail or does it ust paraphrase the MDR?

Given that they are revised every two years, are there enough significant changes (besides the obvious MDR ones) to warrant purchasing this edition over the last one?

------------------------------
Lena Cordie
Qualitas Professional Services, LLC
Victoria MN
United States
------------------------------