Development of Medical Software for 510(k) - Where to start

O

ozalp

#11
Hi Meddi, I agree with Sagai 100% (especially about the mental state). Being in the industy for more than 10 years, it happens to most of us.

To be more serious, I also agree with Sagai with all the materials you have to read.
From the software development perspective, if you follow strict (IEEE like) development principles and have a well documented software and good TRACEABILITY (a very important concept for FDA) you are in good shape.

Besides, no matter how many files or folders you submit to FDA what they first look at is if this device is safe for its INTENDED USE (another very important concept).
Also, you have to know the Classification and Criticality of this device, which determines the DESIGN HISTORY FILE content for 510 K submission.

In Sum, if you have good documentation of your software and if you can trace this data from REQUIREMENTS to DESIGN to TESTS and to CODE, and if you can prove (in writing) that the device software behaves as intended with no MISHAPS (it is called safety analysis), then no matter what the criticality or Classification of this device is, you are in good shape.

Please feel free to ask more questions.

Good luck.
 
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