Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
COURSE AGENDA
Definition: Medical Device or Personal Protective Equipment
Overview of Global Medical Device IndustryMedical Device Types
Standard
Active Implanted
In Vitro Diagnostic
Combined Medicinal / Device- Interface with Other Directives
An Overview of the Medical Device Directives
Development, aims and planned implementation of the Medical Device Directives
Implication of EU Directive vs. Regulation
Medical Devices (MDD), Active Implanted Medical Devices (AIMDD), In Vitro Diagnostic Medical Devices (IVDMD), Combined Medicinal / Medical Device Products
Update on the additional guidance documents relating to the directives
Essential Requirements
Classification of MD's and Process Implications / Path by Device Type
Conformity Assessment
Technical File
Relationship to EU Clinical Trial Directive
Guidance Documents Medical Device Directive Annexes
Courses by Type
Certification Programs
& Transportation
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