This is a collection of Provision, Procedure, and Forms for design control in a form consistent with the FDA QSR.
In the QSR (Quality System Regulations),
・Design and development plan
・Design Inputs
・Design Output
・Design Review
・Design verification
・Design validation
・Design Transfer
・Design Change
・Design history file
The QSR (Quality System Regulation) requires procedure such as
QSR (Quality System Regulation) requires risk analysis, not risk management,
risk analysis, not risk management.

List of Forms
The following forms are included with your purchase.
・00 MD-QMS-K4 Design Control Provision
・00 MD-QMS-S401 Design Control Procedure
・MD-QMS-F401 DR Minutes
・MD-QMS-F402 DR Follow-up Sheet
・MD-QMS-F403 DR Certification Form
・MD-QMS-F405 Traceability Matrix
・MD-QMS-F406 Design Verification Approval Form
・MD-QMS-F410 Design Input Approval Form
・MD-QMS-F415 Design Output Approval Form (Basic Design)
・MD-QMS-F416 Design Output Approval Sheet (production prototype design)
・MD-QMS-F420 Design Transfer Record
・Product Development Plan (sample)

Table of Contents

Provision

1 Purpose
2 Scope
3 Definitions
4 Design review meetings
4.1 Design review
4.2 Meeting responsible department and participating departments
4.3 Follow-up for the meeting absentees
5 Medical device lifecycle
6 Procedures
6.1 Business plan development stage
6.1.1 research investment
6.1.2 Business plan development
6.1.3 New product planning
6.2 Product development planning stage
6.2.1 Preparation of product development plan
6.2.2 Risk management planning
6.2.3 DR for new product development planning (DR0)
6.3 Design input stage
6.3.1 Risk analysis
6.3.2 Usability engineering evaluation
6.3.3 Preparation of design input
6.3.4 DR for design input (DR1)
6.4 Design output stage
6.4.1 Basic design step
6.4.2 Production prototype design step
6.4.3 DR for design output (DR2)
6.5 Design verification stage
6.6 Process design and transition to mass production (preparation for design transfer) stage
6.7 Design validation stage
6.8 Design transfer stage
6.9 Design change / 4M change
6.1 Design history file (DHF)
6.10.1 Maintenance of DHF
6.10.2 Preparation of DHF
6.10.3 Approval of DHF
6.11 DHF storage
6.12 Documents and records to be maintained in DHF
7 Approver of the deliverables
8 Records retention
9 CAPA criteria
10 Reference
11 Supplementary provision

Procedure

1 Purpose
2 Scope
3 Definitions
4 Roles and Responsibilities
5 Main responsibility of each department
6 Procedures
6.1 Business plan development stage
6.1.1 Preparation of new product planning summary
6.1.2 product development plan preparation
6.2 Product development planning stage
6.2.1 Preparation of Product development plan
6.2.2 Risk management planning
6.2.3 DR for new product development planning (DR0)
6.3 Design input stage
6.3.1 Materialization of user requirements
6.3.2 Materialization of product requirements
6.3.3 Risk analysis
6.3.4 Usability engineering evaluation
6.3.5 Preparation of design inputs and team review
6.3.6 Trackability matrix issuance
6.3.7 DR for design input (DR1)
6.4 Design output stage
6.4.1 Basic design step
6.4.2 DR for design output（DR2-1）
6.4.3 Production prototype design step
6.4.4 DR for design output (DR2-2)
6.5 Design verification stage
6.6 Process design and transition to mass production (preparation for design transfer) stage
6.7 Design validation stage
6.8 Design transfer stage
6.8.1 Design transfer activities
6.8.2 DR for design transfer (DR3)
6.8.3 Approval for design transfer
6.9 Design change
7 Design History File (DHF)
7.1 Preparation of DHF
8 Records keeping
8.1 Records keeping DHF
8.2 Records keeping of DMR
8.3 Records retention period
9 Request for CAPA
10 Forms
11 References
12 Supplementary provision