1. Overview This checklist is used to verify the completeness and consistency of the Clinical Evaluation Report against the requirements outlined in Appendix A10 of the MEDDEV 2.7/1 revision 4 Guideline. Note: This checklist is sourced from Appendix A10 of […]
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The Clinical Evaluation Plan outlines the methods for developing and updating the Clinical Evaluation Report. This plan is revised as needed by post-market clinical follow-up, such as when new search criteria are added for literature searches. Although the content of
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Transfer this table to an Excel sheet for better literature management. Adjust it to meet your specific needs and requirements. Search Category No. Reference Potentially Relevant? Relevant After Full Text Review? Title PUI/PMID Abstract Comments Device Name / Equivalent Device
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