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Nexplanon, Manufacturing - Coggle Diagram
Nexplanon
Meeri Härmä, 151053171
Manufacturing
Clinical & performace evaluation
Post-market surveillance
continuous process
Reviews on regulatory compliance
Regulatory:
EU
Notifying the competent authorities
National authorities, e.g. Fimea
Notified bodies
Declaration of conformity
USA
FDA
Pre-market approval
Clinical research
Clinical testing
Additional testing for new features
required for market approval
Risk assessment
Idea
Reseaching the feasibility
similar products e.g. Implanon
clinical background
methods and manufacturing research
preclinical work
Strengthening the concept
design validation
EU
Notification for the clinical investigation
Application for the MDR
Approval from the ethical review board
USA
Investigation Device Exemption application