supporting documentation

[bewest]

Need

• level of concern
• system/app hazards analysis
• system/architecture description
• address listed questions by FDA

See also:

• http://www.accessdata.fda.gov/cdrh_docs/reviews/DEN140038.pdf
• http://santoslab.org/pub/mdcf-architect/_downloads/PulseOx_Forwarding_System.html#spo2_to_display
• http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM429672.pdf
• http://www.osehra.org/sites/default/files/0830-chapman_open_source_9-26-2011.pdf
• http://santoslab.org/pub/mdcf-architect/hazard/overview.html#hazard-analysis-overview
• http://samprocter.com/wp-content/uploads/2012/06/memocode14.pdf

[bewest]

Documentation is updated most frequently when close to the source. Proposal is to use continuous publishing to automatically analyze the repo contents on each commit, ripping out the needed documentation, and publishing the results as part of the automated test suite. The test suite should output json and markdown archive of the analysis. These tools allow transforming source files into markdown:

• https://github.com/jsdoc3/jsdoc - jsdoc can analyze annotated/markdown documentation from source
• http://jsdox.org/#examples
• https://github.com/75lb/jsdoc-to-markdown
• https://github.com/75lb/dmd

Introducing tags like @hazard allows the json export, and thus the templates to assemble special hazards reports and other deliverables, we can use pandoc and friends to automate re-rendering between pdf, html, and other outputs:

• https://github.com/karthik/markdown_science
• http://johnmacfarlane.net/pandoc/scripting.html
• https://www.npmjs.com/package/pandox
• https://github.com/jgm/pandoc/wiki/Pandoc-Filters
• https://github.com/mvhenderson/pandoc-filter-node

This approach makes it easy to combine light-weight, easily maintained prose documents in markdown with automatically compiled results, using static analysis of the repo and source to create a comprehensive suite of documentation.

Building in travis allows using submodules and other arbitrary tools, and also allows pushing the "build artifacts" to a protected resource.

I've only explored toolchains to help with javascript, but suspect there are tools that can perform similar tasks for objective c, java, and others if needed.

[bewest]

I got carried away with some of the technical things earlier, I've since stubbed out at least 4 high level, prose documents, I think most people can help out with in some way.

I tried to focus on "what" hoping we can find a way to recycle or re-use or perhaps even enhance existing documents.

[bewest]

See http://nightscout.github.io/posts/2015-02-28-proposed-roadmap/, #3 for how this fits in with grand scheme of things.

In summary:

1. Monitor
2. Predict
3. Control

is a very broad, rough outline for general iterative roadmap, this discussion of approval vs ongoing compliance is unique to Monitoring phase only, preparing groundwork for the more advanced work.

[bewest]

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/UCM290561.pdf

[bewest]

[bewest]

Here are our minutes from the last meeting: https://gist.github.com/bewest/ed7b0e4965442252f6a8#file-minutes-md