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What means Sufficient Clinical Data with Bassil Akra (EU MDR)
You are maybe trying to build your Clinical Evaluation Report or your PMCF for a Medical Device. And you are stuck because you don’t really understand what means Sufficient Clinical Data?
Then listen to this interview with Bassil Akra from QUNIQUE Group, who is sharing with us his experience as a former TÜV SÜD auditor.
He also participated in the different groups to prepare the guidance that we will discuss today.
During this interview we will discuss:
The difference between MDD 93/42/EC or AIMDD 90/385/EEC and MDR 2017/745 in terms of clinical data
The meaning of Sufficient Clinical…
The skinny
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