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.