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clinical application (development process (FINAL DESIGN:design and…
clinical application
development process
PROJECT DEFINITION:initialisation/opportunity and risk analysis
financial review
market analysis
competitive assessment
early risk assessment
legal/IP analysis and filings
regulatory and clinical path
reimbursement path
INITIAL DESiGN:formulation/concept and feasibility phase
core team selection
general project plan
customer input
customer prototype evaluation
early concept selection
prototype analysis
initiate & maintain design history file
initiate design risk analysis
IP landscape review&review od filings
initiate regulatory strategy
initiate DFM
FINAL DESIGN:design and development/verification and validation
customer prototype evaluation
product design development
design verification and validation
maintain DHF and project timeline
design risk analysis
patient review
regulatory strategy update
regulatory submission
reimbursement strategy update
supplier collabotation
detailed ptoducibility
clinical validation plan
PRODUCT LAUNCH:final verification/product launch
product branding
market launch plan
dhf completed
dfmea review&update
final patent review with R&D
obtain regulatory approval
finalize reimbursement strategy
medical devices
classification