PMCF Report
The PMCF report plays an important role in conducting research and demonstrating the safety of the device.
This data can be used to identify and review potential risks in the course of action.
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The PMCF report should consider the following :- Follow clinical trials or research plans and complete reports.
- Include analysis data, including the conclusions determined in accordance with the plan analyzed by the appropriate expert
- The conclusions of the final report should be determined based on the goals and hypotheses of the existing clinical trials.
PMCF reports can be used as evidence of clinical trials and clinical evaluation procedures. This requires continuous verification of whether the medical device meets the required requirements, which may be modified or preserved. If manufacturing processes change, design changes, or public requirements change, PMCF should be carried out and the report rewritten. This report must be reviewed and managed by the certification authority.
DNA TECHNOLOGIES PACIFIC does the following with respect to the PMCF
5Continuous data collection helps identify and manage residual risks.
- NA Technologies Pacific's experts will support clients' PMCF implementations with many years of experience.