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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
