Clinical Evaluation and Summary of Safety and Clinical Performance
Fulfillment of Regulatory Requirements per Article 61, Annex XIV Part A and Article 32
Planning, Assigning Responsibilities and Identifying Data Sources
Collection, Appraisal, and Analysis of Clinical Data
Reporting and Transferring Data to Quality Management System
Post-Market Surveillance
Fulfillment of Regulatory Requirements per Article 83-90, Annex XIV Part B
Planning, Assigning Responsibilities and Designing Device-Specific Clinical Follow-Up Studies
Collection and Analysis of the Clinical Data
Reporting and Transferring Data to Quality Management System
Usability Engineering in Medical Devices
Conducting a Usability Engineering Process under IEC 62366-1 and TR/IEC 62366-2
Formative and Summative Surveillance Methods
Biological Evaluation
Fulfillment of ISO 10993-1 and -18 requirements
Device-Specific Risk-Based Approach and Gap Analysis
Identification of Chemical and Physical Characterization Methods
Plan and Report Templates
Risk Management Process in Medical Devices
Fulfillment of Requirements under ISO 14971 ISO/TR 24971
Risk Management Plan and Identification Risk Assessment and Estimation Method
Collection of the Data
Reporting and Transferring the Data and Reviewing Risk Management Process
Accompanying Documents
ISO 15223 and 20417 requirements
Assessment of the Consistency of Data through Technical File
