Clinical Evaluation Systematic Literature Review - Apec-ahc.org

Clinical Evaluation Systematic Literature Review
Partial Contents
• Introduction
• Description of underlying health problem
• Current treatment options and interventions
• Description of currently used medical devices and maturity of technology
• Description of medical device under assessment
• Intended function
• Technology, critical performance criteria and design
• Method of use and instrumentation
• Indications
• Contra-indications
• Intended clinical setting, user profile and training requirements
Summary of Risk Analysis Performed
• Risk analysis for the intervention for which the total knee implant
is intended was performed including:
• Early postoperative
• Late postoperative
• Warnings and Precautions
• Adverse Events
• Other
• Risk analysis for the particular technical solution adopted
• Risk analysis specific to the design and use of the subject device
and total hip replacement
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