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Various Updates #2

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Binary file modified Device.Description.docx
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17 changes: 11 additions & 6 deletions OVF controlled documents.csv
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@@ -1,6 +1,11 @@
,Subregister of controlled documents relevent to the Open Voice Factory ,,
,Master list of controlled documents availible from eQuality Time on request ,,
Name,Filename,Reference ,Location
OVF Risk Assessment,OVF.risk_.assessment.xlsx,https://github.com/joereddington-public/MHRA-Technical-File/blob/master/OVF.risk_.assessment.xlsx,https://github.com/joereddington-public/MHRA-Technical-File/blob/master/OVF.risk_.assessment.xlsx
eQT Document Management Policty ,Document.Management.Policy.docx,,
OVF Device Description,Device.Description.docx,,
Subregister of controlled documents relevent to the Open Voice Factory ,,,,,
Master list of controlled documents availible from eQuality Time on request ,,,,,
,,,,,
Name,Filename,Reference ,Version,Status,Location
Quality Manual,Quality.Manual.docx,1001,V0.1,Draft,
eQT Document Management Policy,Document.Management.Policy.docx,1001,V1.2,Draft,
OVF Device Description,Device.Description.docx,1002,,,
OVF Declaration of Conformity,OVF.declaration.of.conformity.docx,1003,V0.1,Draft,
OVF Risk Plan,OVF.risk.plan.docx,1004,V1.0,Approved,
OVF Statement of Essential Principles,OVF.statement.of.essential.principles.docx,1005,V0.1,Draft,
OVF Risk Assessment,OVF.risk_.assessment.xlsx,1006,V0.6,Draft,https://github.com/joereddington-public/MHRA-Technical-File/blob/master/OVF.risk_.assessment.xlsx
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23 changes: 22 additions & 1 deletion README.md
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# MHRA-Technical-File
# MHRA-Technical-File for The Open Voice Factory

##Contents
1. Device Description and Specification
1. Declaration of Conformity
1. Statement of Essential Principles
1. Release Note
1. Test Cases and Test Report
1. Risk Report and Risk Register
1. Clinical Evaluation

###Quality Management System
1. eQuality Time Quality Manual
1. Document Management Policy
1. Development Policy
1. Risk Policy
1. Post Market Surveillance Policy
1. Continuous Improvement Policy

###Records
1. Roadmap