Software in Medical Devices, by MD101 Consulting

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How to develop a smartphone App to be FDA-cleared or CE Marked? - part 6 Conclusion

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:

  1. 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,
  2. Choose the standards that you're going to apply (see this post about standards to have some more tips),
  3. 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),
  4. 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,
  5. 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!

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