Document #: SGW/2020/PDC/V2.4		Product Specifications	>	Product Design and Development		>	Verification and Validation		>	Production
		Phase 1		Phase 2	Phase 3		Phase 4	Phase 5		Phase 6
Product Development Process  >>		Product Definition	>	Concept Development	Engineering Design	>	Prototyping and Testing	Tooling and Pilot Run	>	Manufacturing and Support
ISO 13485:2016 Certified, US-FDA Registered Class 100,000 Clean Room Manufacturing		Market Strategy, Configuration, Design Features & Specifications, Project Planning, Communication		Design Requirements, Concept Designs & Refinement, Features, User Interface Development	Detail Component Engineering Design, Hardware Development, Software Development & Testing		Prototyping, Device Verification, Performance and Safety Testing, Regulatory Submission Support	Tool and Process Development, Pilot Batch, Device Validation, Assembly Process and Logistics		Supply Chain Management, Support and Service Setup, Manufacturing Handovers
Business Development		Market Analysis, Product Configuration, Design Features & Specifications, Make Project Plan	G A T E R E V I E W	Design Requirements Finalisation, Customer Review, Concept Finalisation	Design Output, Features, Cost Estimation, Customer Review Coordination	G A T E R E V I E W	Design Output Verification, GUI Verification, Features Verifications, Customer Review	Customer Approval of Tool Investment, Lead time, Project Plan, Launch Schedule	G A T E R E V I E W	Coordinate for Production Order, Initial Support, Business Development Support
Project Management
Industrial Design		Design Directions, Customer requirements understanding		Concept Development, Customer Review, Refined Concept Design User Interaction Development	Components and Assembly design. Review and Verification, Hardware & Software Development		Packaging Design, Product and Process Verification, Tooling Planning, Process Sheets	Engineering Design Release for Tooling, Review of Tool Design,		Periodic Review of Product, Engineering Change Management
Engineering Design
Prototyping		Understanding of Project, List of Applicable Standards		Concept Design Review, Preparation of Lab Testing Requirements, Risk Management	Engineering Design Review, Critical Component List, Preparation of Risk Management		Configuration Verification, Conduct Performance and Safety Tests, Reliability Testing	Collate Lab Test Reports, Coordinate with Engineering for Technical File and Regulatory Submissions		Periodic Review of Process, Process Parameter Calibration and Verification
Regulatory Support
Engineering Development		Tentative BOM Cost Estimation, Tooling Cost Estimation		Concept Design Review, Process Cost estimation	DFM, Component and Assembly Review, Process Engineering and Critical Design Review		Tool Planning for Moulds, Dies, Fixtures, Quotations, Customer Coordination	Customer Training, Product Calibration & Testing, Device Master Record Formats		Product and Process Optimisation, Continuous Improvements, Review
Process Engineering
Manufacturing		Selection of Bought Out Components, Supply chain, Processes Assessment		Bough out Parts Review, Parts and Process Standardisation	Process and Assembly sequence review, Standard components, Special Processes Fixtures		Supplier coordination for Components, Specifications, Cost, Quantities and Time	Supplier Coordination, Cost Optimisation, Work Instructions		Supply Chain Management, Support and Service, Ordering, Manufacturing Handovers
Supply Chain, Logistics
Project Records and QMS Documentation		Design Inputs, Product Configuration, Features, Specifications, Project Planning		Requirements, Concept detail Presentations, Customer Reviews Points, Gate Review Documents	Design Reviews, Design History File, BOM, Datasheets, Engineering Drawings		Prototype Reviews, Process Sheets, Tooling List, Process Parameters, Collate Testing Lab Reports,	Tool Parameters, Product test & Calibration and Approval, Validation, DMR documents		Manufacturing and Testing Documentation, Service Documents, BOM, BOI Documents
© Sigowill, All Rights Reserved					*This is Sigowill's Standard Product Development Process, which may vary depending on the Product and Customer needs. Specific details will be determined during the project planning phase.