How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion
By Mitch on Friday, 14 February 2014, 12:48 - Misc - Permalink
To conclude this series about clearance of mobile medical apps, here are a few tips to newcomers in the world in medical devices.
There aren't so many things to pay attention to. the list is quite straightforward:
- Verify if your app is deemed a medical device, according to regulations. To quote the most obvious case, FDA is notoriously more strict than European Union,
- Choose the standards that you're going to apply (see this post about standards to have some more tips),
- Have a look at guidances provided by regulation authorities, FDA guidances (see this page about guidances) and EU MEDDEV Guidances (not so interesting though, see this article about CE marking software instead),
- Manage your company processes to be ready to pass a clearance process, should it be 510k or CE mark audit by notified body, even if at the very beginning, you thought this wasn't applicable to you,
- Be careful with constraints imposed by owners of mobile applications stores.
And before launching the development of a new app, take some time to make a feasibility study with:
- Preliminary functional specification inc. intended use,
- Preliminary risks analysis.
Output of both preliminary studies will help a lot in the realization of steps 1 to 5.
Have a nice journey in the world of mobile medical apps!
