Clinical 1 hour (Introductory price)

I. Clinical Evaluations Plans & Reports
II. Performance Evaluation, Performance Studies, and Clinical Evidence Including Scientific Validity, Analytical Performance, & Performance Plans and Reports
III. Clinical Research – Development Plans, Statistics, Protocols & Reports, Informed Consents, Case Report Forms, Site Selection, Monitoring, Investigator Brochure, Auditing, and Public Postings
IV. Risk Management Including Product, Software, Clinical, and Cybersecurity. Also Root Cause, Usability, Human Factors, Complaints, Vigilance, and Field Actions
V. Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) or Post-Market Performance Follow-up (PMPF)
VI. Summary of Safety and Clinical Performance (SSCP) or Summary of Safety and Performance (SSP)
VII. PMS Reports
VIII. Periodic Safety Update Reports (PSURs)
IX. Surveys
X. Meta-Analysis
XI. Claims & Extended Indications
XII. Presentations and Publications