Clinical Study Protocol

Clinical Evaluation Plan (CEP)

Clinical Evaluation Report (CER)

Summaries of safety & Clinical Performance (SSCP)

Post-Market Clinical Follow-up Plan (PMCF Plan)

Post-Market Clinical Follow-up Report (PMCF Report)

Periodic Safety Update Reports (PSUR) and Post-Market Surveillance
Report (PMSR)

Clinical Literature Search and Review

IFU and User Manual

Clinical Study Report

Informed Consent Document

Clinical Study Protocol

Investigator Brochure

Subject Narrative

Package Insert (Prescribing Information)
& Patient Information Leaflet