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The design and development stages,
The review, verification and validation that are appropriate to each design and development stage, and
The responsibilities and authorities for design and development.
References & Documents
Design Specification Requirement (Use Standard if Applicable)
Intend to Produce
State of Art Design
Material Choice & Selection (Biocompatible & Safety)
Information on Safety & Performance from Similar Design
Identify, Evaluate & Control the Associated Risk
Moulding Process Suitability
Needle Tipping and Bending Suitability
Assembly Process Suitability
Packaging Suitability
Sterilization Suitability
Manufacturing Process
Engineering Drawings
IFU, Label Design & Artwork
Product Specification with Acceptance Criteria
Characteristics & Functional Performance
Identify any problems and propose necessary actions
D & D output meets the D & D requirement
Validate the claim & Characteristics towards Safety &Performance
Changes shall be reviewed, verified & validated as appropriate, and shall be approved before implementation
