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An introduction to Performance Evaluation, Performance Evaluation Plan, Science Validity and link to PE report and conclusion
Performance Evaluation under the IVDR part 1.
Conduct and document a performance evaluation.
Manufacturers demonstrating scientific validity.
Performance Evaluation Report.
Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR) in part 1 of this series.
Global Head - IVD, BSI.
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