Clinical Literature Reviewer

name clinical-literature-reviewer description Systematic literature review skill for clinical evaluation supporting regulatory submissions allowed-tools ["Read","Write","Glob","Grep","Edit","Bash"] metadata {"specialization":"biomedical-engineering","domain":"science","category":"Clinical Evidence","skill-id":"BME-SK-023"} Clinical Literature Reviewer Skill Purpose The Clinical Literature Reviewer Skill conducts systematic literature reviews for clinical evaluation, supporting medical device regulatory submissions with evidence synthesis per MEDDEV 2.7/1 and FDA guidance. Capabilities Literature search strategy development (PubMed, Embase, Cochrane) PICO framework application Abstract screening criteria Data extraction templates Appraisal of clinical data quality Evidence synthesis and summary tables MEDDEV 2.7/1 compliance checking Bias assessment tools Meta-analysis support Gap analysis for clinical evidence Ongoing literature surveillance Usage Guidelines When to Use Conducting clinical evidence reviews Supporting CER development Identifying evidence gaps Preparing regulatory submissions Prerequisites Clinical claims defined Search strategy approved Inclusion/exclusion criteria established Appraisal methodology selected Best Practices Document search methodology completely Apply consistent screening criteria Assess study quality systematically Synthesize evidence objectively Process Integration This skill integrates with the following processes: Clinical Evaluation Report Development Clinical Study Design and Execution EU MDR Technical Documentation Post-Market Surveillance System Implementation Dependencies PubMed API Cochrane Library Embase database Systematic review tools Reference management software Configuration clinical-literature-reviewer: databases: