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Opportunity and Risk Analysis

Opportunity and Risk Analysis
1Pages

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Target identification, biomarker discovery Market analysis Patent and publication reviews Benefit-risk determination Opportunity and Risk Analysis Collection of appropriate samples Biomarker qualification Prototype assay Assay Feasability Assay qualification Analytical validation Definition of Critical Parameters Robustness of test Contractualization with suppliers 1st and 2nd tier Total Cost of Ownership Design of the test Patient selection, anonymization Diagnostic specificity and sensitivity, analytical and clinical performance Small scale manufacturing Delivery to Clinical centers Clinical Data Filing according to the Quality Management System (QMS), manufacturing, technical description, clinical data, evidence of efficiency, transportation, packaging Premarket approval (PMA) submission Manufacturing, conditioning Quality Control Pricing | cost final decision Supply & retail chain consolidation Stock Delivery Sales Product Launch Life cycle management Reporting Preventive | corrective actions Data | sales volumes | estimates of user population and frequency of use Post market performance follow-up Regular updates and with additional features and capabilities Post Market Surveillance

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Opportunity and Risk Analysis 1Pages

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Opportunity and Risk Analysis
1Pages