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English to Japanese translations [PRO]
Medical - Medical: Instruments | | English term or phrase: device iterations | | After obtaining clinical information from an early feasibility study, the type of subsequent clinical evaluation will depend on the stability of the device design, the availability of adequate data to justify the next study, and the purpose of that clinical study. Early feasibility studies involve the investigation of devices that may be in a rapid phase of device iteration. If clinical information is needed after device modification and further device iterations are expected, sponsors may submit an IDE supplement including a request for expansion of the early feasibility study to FDA. |
| sasukeKudoZ activityQuestions: 541 (none open) ( 19 without valid answers) ( 5 closed without grading) Answers: 0
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| | 機器のイテレーション | Explanation:
憶測で申し訳ないですが、医療機器の製造・実用化に向けたフィージビリティスタディ（実施可能性調査)の内容だと思います。 臨床現場で正しいデータ（妥当性のある臨床評価）を得ることも大事ですし、その安全性も確かめておく必要があると思います。early feasibility studyは、特に安全性について調査するのだと思います。 ここでのイテレーションというのは、ソフトウェアの開発でも使われるものと類似しているのではないかと思います。 「イテレーション」は開発分野の用語となっているようです。
1つの反復 (イテレーション) で1機能を開発する反復型開発。 または、 開発を小さなステップの繰り返し (イテレーション) に分けて行う等。
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc...
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Note added at 5 days (2011-12-21 06:54:33 GMT) Post-grading
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or 反復型（イテレーション）開発。(o・・o)/ |
| Selected response from:
  Mami Yamaguchi
| Grading comment 説明がわかりやすくて助かりました。ありがとうございます。
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