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IVDR and Performance Evaluation Plan

#1
Hello everyone,
First of all sorry if I'm wrong here - but I haven't found an IVDR forum or thread that fits my question.
I hope you can help me. Can someone explain to me what exactly is meant by:

"an outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria;"

Unfortunately, I have to say that I cannot really imagine what should be queried here. It is a requirement for the Performance Evaluation Plan for IVDs (Annex XIII. 1.1). Does anyone have an idea, or preferably an example?
Many Thanks!!!
 
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#2
Essentially it is exactly what it says. If you are operating to ISO9001 or ISO13485, you should have a design process, and every product should have a design plan that explains the steps of the design process. As an example, this might include development, feasibility, optimization, verification, and clinical validation. You need to describe the milestones and acceptance criteria for each phase of the project.
 
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