Template based development environment setup and requirements of FDA approval

[Dwij_Mistry]

How we can setup a clean development environment?

What we are doing is as follow.

1. We created Template in which we had
   GIT_REPOSITORY git://github.com/Slicer/Slicer
   GIT_TAG 62e4d8544f2a6f30b707a87288a5e1b9fc5a5a86
   (this is a latest commit on 3/12/2021 which is a based on 4.11.20210226 stable patch)
2. build it.
3. we pushed slicersource-src to our GitHub repo.
4. in template we modified
   GIT_REPOSITORY our repo
   GIT_TAG tag id
   So from next time when we are setting up an environment it is taking source code from our GitHub repo.
5. once development environment is set, we are doing required modification in slicersource-src folder which is linked with our GitHub repo. by this we are pushing and pulling changes (So, multiple developers can contribute).

Does we are following correct method for clean development?

Or Is there any way to do
Please tell me your suggestions.

In addition to this, We are planning for FDA approval.

• Does we will get FDA approval by using slicer template based software development? or any other way to achieve?

• What are the requirements to get full FDA approval for the software?

[Sam_Horvath (Sam Horvath (Kitware))]

Forking Slicer to your GitHub organization and then creating a branch in that fork based on your desired Slicer commit would have been a more straightforward method, but achieves the same thing in the end.

With regards to FDA approval, FDA submission is a complicated process that will depend heavily on the intended use of the software. You will need to engage with a regulatory consultant in order to determine the requirements for FDA approval.

[Dwij_Mistry]

@Sam_Horvath

Forking Slicer to your GitHub organization and then creating a branch in that fork based on your desired Slicer commit would have been a more straightforward method

We are using private repo for the development.

@Sam_Horvath

FDA submission is a complicated process

Is there any hardware specification for the development?

Dese we will get FDA approval for full slicer based software or we need to create software from a scratch like ITK, VTK, Qt lib (start from zero)

[pieper (Steve Pieper (Isomics, Inc.))]

I’ll just reiterate Sam’s point that there is a lot to consider if you plan to bring a medical device to market so there’s no simple answer.

A good place to start learning is to take this course and read the accompanying textbook:

Yale course about medical software development

Our friend and colleague Xenios has put together a great set of material about developing medical software. The course is free, or $50 if you want a certificate. There’s a textbook with additional material. I read an earlier draft and there’s a lot of very practical information for anyone working in the field.