Good planning is key - this also applies to clinical evaluation. The foundation for clinical evaluation is laid in the clinical evaluation plan.
What is the clinical benefit of the product and which clinical parameters can be used to demonstrate this benefit? What constitutes a suitable literature review? Are clinical data available for the device or can the clinical data of an equivalent product be used? Which specific features and risks of the device have to be considered?
In the case of new products, it is advisable to address these questions during the development phase in order to choose the correct approach to clinical evaluation at an early stage.
For established products, it is advantageous to develop the plan and the clinical evaluation in a timely manner in order to exploit synergies and reduce costs.
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