Med Device Regs

This app contains the full content of FDA Medical Device Quality System Regulation (QSR) 21CFR820, Medical Device Reporting (MDR) 21CFR803, and Electronic Records; Electronic Signatures 21CFR11.

The FDA regulations are split up by section, click on a section to display just that specific section. Click again to hide. Each section also contains a link to the FDA website which contains the regulation. Swipe to view the additional regulations.

This is handy for auditors and as a general reference, just keep your phone handy instead of carrying around a reference book.