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Medical Device Regulations icon

Medical Device Regulations

SoftwareCPR
1.1 for Android

The description of Medical Device Regulations

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.
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Medical Device Regulations 1.1 Update

2018-05-21
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.

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Additional Information

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Previous versions
  • V1.1 2.0 MB APK

    Medical Device Regulations

    2018-05-21

    Medical Device Regulations 1.1 (3)

    Update on: 2018-05-21

    Requires Android: Android 4.0.3+ (Ice Cream Sandwich MR1, API 15)

    Signature: f3280a72c5ff20a65c89ad8c03617779b60e67dd Medical Device Regulations 1.1(3) safe verified

    Screen DPI: 160-640dpi

    Architecture: universal

    File SHA1: a6763cabfd6c0b6369479f042ebd8bfd85c8b538

    File Size: 2.0 MB

    What's new:

    Download

  • V1.0 2.0 MB APK

    Medical Device Regulations

    2018-03-04

    Medical Device Regulations 1.0 (2)

    Update on: 2018-03-04

    Requires Android: Android 4.0.3+ (Ice Cream Sandwich MR1, API 15)

    Signature: f3280a72c5ff20a65c89ad8c03617779b60e67dd Medical Device Regulations 1.0(2) safe verified

    Screen DPI: 160-640dpi

    Architecture: universal

    File SHA1: 04e0cdf2177c978fcf2d1893176082b41a2ef6e8

    File Size: 2.0 MB

    What's new:

    Download

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