SoftwareCPR 1.1

The SoftwareCPR app offers a streamlined approach to accessing the FDA Code of Federal Regulations (CFR) pertaining to medical devices. Users can conveniently browse key regulations, including:

• 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

In addition to the CFR, the app provides access to essential FDA Guidance Documents, such as:

• General Principles of Software Validation
• Content of Premarket Submissions for Software Contained in Medical Devices
• Content of Premarket Submission for Management of Cybersecurity in Medical Devices

The app enhances usability by allowing regulations to be expanded or collapsed, facilitating efficient offline reading and navigation. It operates without requiring special permissions and is free from advertisements.

For users seeking assistance with interpretation or implementation, the app includes a feature for submitting inquiries via email, ensuring prompt support from expert consultants. Additionally, the developers are committed to regularly updating the app with new guidance documents.