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Certification
What is a certification?
Preparation for a certification (which requirements shall I meet?)
Technical File
Harmonised standards
Essential Requirements
Declaration of Conformity
Certification process
Medical devices
Quality management systems
CE-Marking
What is CE marking?
The route to CE-Marking
Classification of medical devices (which risk class is my medical device?)
Conformity assessment (which procedure applies for my device?)
Conformity assessment - Class I
Conformity assessment - Class Is/Im
Conformity assessment - Class IIa
Conformity assessment - Class IIb
Conformity assessment - Class III
Medical Device Directive 93/42/EEC
ISO 13485
What is ISO 13485?
Risk management
Requirements for the ISO 13485 certification
Difference between ISO 13485 and ISO 9001
Questionnaire Quality Management
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Taiwan
Greece
About us
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