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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
International
International Certifications
Canada
Japan
Taiwan
Greece
About us
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Your benefits of Medcert Certification
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References
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Private Label
Equivalent to trade name; see also
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