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Week 3 Development processes (post-market (Adverse event reporting, Audits…
Week 3 Development processes
Classification
Class I
Class IIa
Class IIb
Class III
Duration of application, invasive, energy supply -> risk
Initialisation/opportunity and risk analysis
Market analysis
Market
Size, growth rate, trend, profit potential, business strategy
Sales
Demand, competition, sales channel, reimbursement
Procurement
Raw material, tools, semi-finished products, job market, energy
Product
Composition, performance, prime cost, regulatory, product testing, merchandising
Finance marketing
Capital market, money market, currency market
Formulation/Concept and feasibility phase
Economically
Financing, market, market size, profitability, reimbursement
IP
Existing IP, patentable features
Regulatory
Requirement for sales area, product, development
Technical
Technical feasibility, reproducibly producible
Clinical
Benefit patient/ user/ payer, fit to workflow
Design and development/verification & validation phase
Plan
Definition
Documentation
Procedure
user requirement
design requirement
component specification
implementaion
component testing
system testing
product tesing
design risk
Final Validation/product launch phase
USA
EU
types
nomative
informative
guiding
post-market
Adverse event reporting
Audits
Track and trace
Sampling and testing
Safety alerts
Recalls