類似医療機器の苦情分析では新たに大きなリスクが発生していない。したがっ

類似医療機器の苦情分析では新たに大きなリスクが発生していない。
したがって、臨床的有効性がリスクを上回っている。

４－７. 結論
Unit Doseを追加に関するリスク評価を行い問題ないことを確認した。苦情情報の分析、臨床評価の実施によって、リスク評価を行い問題ないことを確認した。

結果 (英語) 1:

With similar medical device complaint analysis new does not cause big risks.
Therefore, clinical effectiveness exceeds the risk.

4-7. Conclusion
verified to conduct risk assessment of the additional Unit Dose, no problem. Verify complaint information analysis, clinical evaluation conducted by risk assessment, not a problem.

結果 (英語) 2:

Greater risk does not occur in the new complaint analysis similar medical equipment.
Thus, the clinical efficacy is higher than the risk. 4-7. Conclusion it was confirmed that there is no problem perform the risk assessment on adding the Unit Dose. Analysis of complaint information, by the practice of the clinical evaluation, it was confirmed that there is no problem perform risk assessment.

結果 (英語) 3:

The analysis of medical complaints in great risk does not occur Therefore, at higher than the clinical effectiveness of risk At 4 -- 7 performs additional risk assessment conclusions at the Unit Dose confirmed that there is no problem Complaint information analysis and evaluation, risk assessment, it was confirmed that no problem At