Quick Tip: Treat clinical evaluation as a process, not a report
Insights from a conversation with Florian Tolkmitt
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Ep 16: Clinical evaluation is now more important than ever under EU-MDR
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There is a new scrutiny on clinical evaluations in the European Union. At the same time, medical device manufacturers are challenged to satisfy the new regulatory requirements under EU-MDR because they are no longer able to claim “equivalence” to an existing device under revised criteria.