Author: Bonnie Weiner

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White Paper


What is an ICER and Why Should You Care?

The healthcare environment is changing rapidly and at all levels.  Value used to be defined as the number of procedures, products, or patients.  That is no longer the case and the challenge is therefore to define value, particularly where there are existing…

White Paper


The New World of CER/CRBA Review

Recent experience has suggested that notified bodies are becoming more critical in their review of clinical evaluation reports (CER) or clinical risk/benefit analyses (CRBA).  The format “suggested” in MEDDEV 2.7.1 r3 is now the expected.  What does that mean to you?  It…

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