level of concern description - Githubissues

nightscout / process-controls

Placeholder for documentation on variety of organizational processes in Nightscout.

http://process-controls.readthedocs.org/en/latest/index.html

GNU Affero General Public License v3.0

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level of concern description #7

Open bewest opened 9 years ago

bewest commented 9 years ago

Formal document to agree on de novo, basic risks and hazards, and regulatory pathway with FDA. See https://github.com/nightscout/process-controls/issues/2 for more info.

Can be short, few pages, needs:

[ ] background of apps/software
[ ] agreement on basic risks
[ ] agreement on which regulations to satisfy/how
- de novo with special controls
- develop plan/roadmap to assemble review supporting materials towards approval, with joint plan on maintaining compliance and record keeping