- Evaluation of the present Data
- Definitions, Requirements and Strategies tailored to the Customers Medical Device
- Reference to the Risk Management Demand according to EN ISO 14971
- Implication related to the technical Product Documentation
- Cross referencing to current Requirements of Directive 93/42/EWG and 90/385/EWG
Operating the Process: How we manage the process
- Preselection of the potential Data Bases considered as the source for Clinical Data
- Research of scientific and Medical Data Bases, Examination of related Literature
- Documentation of Review and Selection Strategy
- Cave: Quality Demands on Clinical Data extracted from Literature Research
Conducting the Process: How we make it happen
- Selecting Sources verifying Conformity of Investigations utilizing similar Medical Devices
- Evaluation of Lifecycle Surveillance Data
- Detailed Examination of non-clinical Data, clinical Data and Data from ongoing Experience (GAP)
- Significance and Evidence Level of published Evaluations
- Outlining a Catalogue for Evaluation and Appraisal clinical Data from the Literature Survey
- Issuing of the Survey Results
Final Step: Compiling the Clinical Evaluation Report (CER)
- Arranging data into Framework of Evidence of Compliance with Key Requirements
- Expert in-house assessment of draft CER
- Execution of Sponsor requested Adjustments following first Sponsor Review Cycle
- Second Expert in-house Assessment of revised CER
- Issuing of the Survey Results
- Supplementary Data Recognition
- Assimilation of Modifications after second Sponsor Review Cycle
