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Create the Technical file for MHRA #73
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Things to include in the Technical File
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Excellent. Thanks Greg, Some quick questions:
Next actions:
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QMS = Quality Management System - have updated. Basically it is our policies. |
This document might be useful |
Thank you for adding issues for each of these - that's going to make life easier. :) |
I have been thinking about the roadmap. I decided a visual representation might be helpful so have created this https://docs.google.com/spreadsheets/d/1LhxRgpai2V81J0bDuiULLEfngxrJ050ljg3rrjk0DHg/edit?usp=sharing I think trying activity to organisational goals is a good thing to do. I can imagine linking this to the risk register and have therefore added a stream for this, although it is currently empty. Maybe there are more things to define as goals. The timescales might be highly speculative, but I feel like putting some kind of marker down is a good thing. |
'sprints for comic relief' should probably say "We're putting together a group of stakeholders, who will tell us what they want, and we'll do some agile sprints with out coders to deliver it." does that make sense? |
Looking at #86 - the title doesn't appear to aggree with the text in this issues header - @greg-westnine - please do some expansion. |
We need to submit a technical file to the MHRA so that they can accept The Open Voice Factory as a medical device.
Here's what we need in a technical file for the MHRA (as provided by @greg-westnine):
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