It’s nice to have medical device FDA regulations and guidance accessible without navigating through old websites or lugging printed copies around. Thankfully, SoftwareCPR’s free iOs and Android apps allow you to quickly view medical device regulations and guidance on your smartphone offline! As medical device consultants, we know from experience how important it is to have information available offline when the WiFi is acting up or meeting clients in a secured environment. I’ve personally used this app multiple times and have found that it saves me time looking up FDA regulations and guidance since I already have my smartphone on me at all times. Instead of dusting off your reference books, trying to find your pocket guide, or trying to find the right FDA database, download our free app by searching in the app store for “SoftwareCPR” or click the links above and let this be your easy comprehensive reference guide.
Each app contains the following FDA medical device regulations and guidance:
- 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
To view a regulation or guidance, choose one from the list and collapse/expand the section you want to see. No ads will show up, no internet connection is needed, and we will never sell your data!
If you like the app then please don’t forget to rate us in the app store! Don’t forget to ping us with suggestions, feature requests, or bug reports! We try our best to accommodate everyone and love hearing feedback.