PROPOSAL

● Explore user needs

● Define competitive advantages

● Perform research and pre-feasibility studies / activities

PHASE 1  Definition

● Design and development project initiative

● Clearly define product and customer needs

● Verify the accuracy of estimates made and identified in research and concept stage

   (deliverables, timelines, budjet)

● Plan for development

PHASE 2  Feasibility & Optimization

● Design the product

● Show feasibility of manufacturing at acceptable cost

● Objective demonstration of product requirements to meet customer needs / requirements for intended use

● Design verification

PHASE 3  Verification

● Design freeze by establishing all crititcal parameters

   (e.g. raw materials, composition assay compounds, design of assay execution protocol)

● Demonstrate manufacturing reproducibility at acceptable cost

   (2 R&D lots benchmarked against design requirements)

● Fitness for intended use (accelerated stability studies for indicative shelf life data)

PHASE 4 Technical Transfer

● Transfer manufacturing documents and verification processes to manufacturing site

   (after successful verification phase)

PHASE 5  Validation

● Validation of technical and clinical performance of 3 lots produced by manufacturing site

   (ISO13485 and released by QA)

● Labeling validation lots as "Performance Evaluation Use Only"

● Grouping generated data of validation phase (can be used for filing assay at notified bodies)

PHASE 6  Transfer

● Transfer of all technical data and documentation, complete design history file (DHF)

   and team evaluation to the customer

PHASE 7 Finalisation

● Obtain regulatory approvals according to launch plan

● Authorize the initial launch

● Introduce product to the market

● Monitor product performance in field

● Implement product support

● Initiate market surveillance

● Achieve market acceptance

● Close project and transfer design support to product manager

Customer