clinical-literature-reviewer

# 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 man...