The 3rd APEC-Funded Seminar on Harmonization of Medical Device Regulation, 13th - 17th Jun 2005, Bangkok, Thailand - Seminar Presentations


                                                      
 

To download the files, use the links below.

Attachment(s):

Download file:SG1__Conformity_Assessment.pdf 
 
Download file:SG1__Essential_Principles_of_Safety_and_Performance_of_Medical_Devices.pdf 
 
Download file:SG1__Global_Medical_Device_Nomenclature_GMDN_System.pdf 
 
Download file:SG1__In_Vitro_Diagnostics_and_Global_Harmonization.pdf 
 
Download file:SG1__Principles_of_Medical_Device_Classification.pdf 
 
Download file:SG1__Roles_of_Standards_in_Assessment_of_Medical_Devices.pdf 
 
Download file:SG1__The_European_In_Vitro_Diagnostic_Directive,a_brochure.pdf 
 
Download file:SG2__Overview.pdf 
 
Download file:SG2__Post_Market_Vigilance_and_Surveillance.pdf 
 
Download file:SG2__TGA_Guidlines___Post_Market_Activities,_Guidance_No._11.pdf 
 
Download file:SG3__An_Introduction_to_Design_Verification_and_Validation.pdf 
 
Download file:SG3__Guidance_Documents.pdf 
 
Download file:SG3__Implementation_of_Risk_Management_Principles__Activities_within_a_Quality_Management_System.pdf  Download file:SG3__Introduction_to_SG3.pdf 
 
Download file:SG3__ISO_13485_2000_An_Overview.pdf 
 
Download file:SG3__Process_Validation_Guidance.pdf 
 
Download file:SG3__Quality_Management_Systems_History_and_Evolution.pdf 
 
Download file:SG3__Session_Overview.pdf 
 
Download file:SG4__Auditing,_Session_Overview.pdf 
 
Download file:SG4__Auditing.pdf 
 
Download file:SG5__Clinical_Evidence_An_Overview.pdf 
 
Download file:Work_Group_A__Presentation.pdf 
 
Download file:Work_Group_B__Presentation.pdf 
 
Download file:Work_Group_C__Presentation.pdf 
 
Download file:Work_Group_D__Presentation.pdf