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DOCUMENT DESCRIPTION |
Essential
Requirements Checklist
.PDF format
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Incident Reporting
procedure
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Post Market Feedback
procedure
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Product
Recall and Advisory Notice Issue procedure
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Suite of Procedures covering Post Sales Issues for Class I devices;
eg: ·Incident Reporting · Product Recall · Advisory Notice Issue · Post Market Feedback · Document Maintenance/Control
· Record Keeping · Labelling Control · etc |
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Declaration of Conformity – Self Certification (no Notified Body)
non-sterile and non-measuring |
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Declaration of Conformity - |
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Declaration of Conformity - Class I - Sterile or Measuring (Notified Body Intervention) |
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EN 980 -
Standard - SYMBOLS FOR USE ON MEDICAL DEVICES PDF
Format |
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 8
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ISO 9004:2000 - Guidance on implmentation of ISO 9001:2000 |