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SG3/N15R8 Risk Management
GHTF
Implementation of risk management principles and activities within a Quality Management System
SG2/N68R3 Where to Send Adverse Event Reports
GHTF
Summary of Current Requirements for Where to Send Adverse Event Reports
SG2/N47R4 Post Market Surveillance
GHTF
Review of Current Requirements on Post Market Surveillance
PMS PPR brief overview AU CA US JP EU
2004/108/EC ElectroMagnetic Compatibility
EMC
Electromagnetische compatibiliteit
89/336/EEC
2004/108/EG
89/336/EEG
MEDDEV 2.10/2 rev.1 Annex 1
NB selection Attachement 1
Qualification of personnel
Guidance on the preparation of a curriculum vitae for a Medical Device
Expert; example of a form
MEDDEV 2.14/2 rev. 1 Research Use Only
RUO
IVD
MEDDEV 2.5/9 rev.1 Rubber latex
Evaluation of medical devices incorporating products containing natural rubber latex
SG3/N99-10 Process Validation Guidance
Quality Management Systems -Process Validation Guidances