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Required DHF / Document 設計開發流程圖 (DHF (1-Concept Stage (Project proposal…
Required DHF / Document
設計開發流程圖
DHF
1-Concept Stage
Project proposal & Review Sheet
3-Design & Development Stage
Design / Development Review Sheet
1-Product characteristic comparison Table
2-Prototype / working sample
3-product specification/function description
4-Engineering BOM
5-Key component list
6-Drawing
7-Circuit diagram
8-Design validation plan & list
9-Producibility / analysis process apecification
10-Design verification protocol & list
11-software validation plan
12-SE discussion
13-Supplier/evaluation/ agreement
14-Usability specification
15-Interface with other equipment/ evaluation/report
16-Life time/shelf life test protocol
17-Clinical investigation plan
18-Labeling & package
19-Usability validation plan
20-Required installation & servic
4-Design Validation Stage
Design / Development Verification Review Sheet
1-Design verilfcation report
2-Usability validation report
3-Risk Analysis (DFMEA & UFMEA)
4-software validation
5-Bio compatibility evaluation report
6-Engineering / pilot production plan
7-eng.QC plan
8-eng. Production working instruction
9-eng.SIP
10=Transportation/package evaluation report
11-Life time/ shelf lift test
12-Other applicable standard evaluation report
13-Phthalates containing & marking
14-Mold/die qualification report
5-Design Verification Stage
Design / Development Validation Review Sheet
1-Pilot production report
2-risk Analysis (PFMEA)
3-Clinical evaluation investigation report
4-Design validation report
5-essential requirement check list
2-Researching & Planning Stage
Design / Development Plan & Review Sheet
8-Mockup draft drawing/ photo
7-Risk management- risk analysis
6-Input of usability specification
5-Essential principle/ essential requirement identifiction
4-Guidance list
3-Applicable standards
2-Clinical research (literature)
1-Project schedule
9-Software requirement specification
10-Design Matrix
6-Design Transfer Stage
Design / Development Transfer Review Sheet
1-Pilot production review report
2-Drawing
3-Circuit diagram
4-BOM
5-QC plan
production working instruction
7-SIP
8-Sample approval sheet
9-Production equipment/fixture list & 3Q report
10-QC equipment list & 3Q report
11-Operator/ QC training record
12-Environmental validation report
13-Risk mang. summary report
14-Technical file review check list
15-DMR check list
1-Red item is the stage review sheet, must to have during stag review
2-Yellow items are design for MDD/IVDD compliance
3-Green item are design for FDA 510 K submission
4-Documents specified in gray should be available during the stage review if appropriate
5-Document number rule : Please refer to ME-QW-001-01 the numbering system
6-Drawing, SIP, production working instruction are not follow this numbering system.
Number of SOP & production working instruction from stage 6 are control by DCC, please contact with DCC.