diff --git a/Device.Description.docx b/Device.Description.docx index 5c6f6eb..aa406f1 100644 Binary files a/Device.Description.docx and b/Device.Description.docx differ diff --git a/Document.Management.Policy.docx b/Document.Management.Policy.docx index b9ff6ca..a3a55b0 100644 Binary files a/Document.Management.Policy.docx and b/Document.Management.Policy.docx differ diff --git a/OVF controlled documents.csv b/OVF controlled documents.csv index c629bf2..4d1a465 100644 --- a/OVF controlled documents.csv +++ b/OVF controlled documents.csv @@ -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,, \ No newline at end of file +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 diff --git a/OVF.risk_.assessment.xlsx b/OVF.risk_.assessment.xlsx index e2cb350..820186d 100644 Binary files a/OVF.risk_.assessment.xlsx and b/OVF.risk_.assessment.xlsx differ diff --git a/README.md b/README.md index cc2ca77..9e51882 100644 --- a/README.md +++ b/README.md @@ -1 +1,22 @@ -# 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 +