APKPure Appを使用する
Medical Device Regulationsの旧いバージョンをダウンロードすることが可能
医療機器のための連邦規則のFDAコード（21 CFR）
An app by SoftwareCPR (http://softwarecpr.com) that provides an easy way to browse and navigate through all FDA Code of Federal Regulations (CFR) related to medical devices, such as:
21 CFR 801: Labeling
21 CFR 803: Medical Device Reporting
21 CFR 806: Medical Devices; Reports of Corrections and Removals
21 CFR 820: Quality System Regulation
21 CFR Part 11: Electronic Records; Electronic Signatures
Guidance: General Principals of Software Validation
Guidance: Content of Premarket Submissions for Software Contained in Medical Devices
Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Regulations and guidance can be expanded/collapsed for easy reading and navigation. Requires no special permissions and contains no ads! Need help with interpretation or implementation? Submit an email from within the app to receive quick help from expert consultants.
最新バージョン 1.1 の更新情報
Last updated on 2018年05月21日
Newly redesigned homepage!
New FDA guidance added:
-Guidance: General Principals of Software Validation
-Guidance: Content of Premarket Submissions for Software Contained in Medical Devices
-Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Fixed back-button action. Pressing the back button on the phone will now go back to the home page rather than closing the app.
翻訳中...
Medical Device Regulations
SoftwareCPR1.1 by Paul Felten
2018年05月21日