How to Implement Design and Development per ISO 13485 7.3
Complete guide to design controls aligned with ISO 13485 and FDA QMSR
FDA QMSR Update
FDA's Quality Management System Regulation (QMSR) final rule aligns FDA requirements with ISO 13485. The previous 21 CFR 820.30 design controls are being replaced with ISO 13485:2016 requirements. This guide reflects current FDA QMSR alignment.
Overview
What is Design and Development?
ISO 13485 Clause 7.3 defines the design and development process for medical devices. It ensures devices are designed to meet user needs, regulatory requirements, and quality standards. The process includes planning, inputs, outputs, review, verification, validation, transfer, change control, and file maintenance.
Why is it Important?
- Ensures devices meet user needs
- Required by ISO 13485 and FDA QMSR
- Prevents costly design errors
- Supports regulatory submissions
ISO 13485 7.3 Structure
7.3.1
Planning
7.3.2
Design Inputs
7.3.3
Design Outputs
7.3.4
Design Review
7.3.5
Verification
7.3.6
Validation
7.3.7
Design Transfer
7.3.8
Design Changes
7.3.9
Design Files
Design Process
Design Planning
Design Inputs
Design Outputs
Design Review
Design Verification
Design Validation
Design Transfer
Design Changes
Design Files & Documentation
Design Reviews
Review
Review
Review
Review
Review
Review
Design Planning
ISO 13485 Clause 7.3.1 - Establish the foundation for design controls
1. Create Design and Development Plan
Document your approach to design and development. The plan should include stages, responsibilities, and review points.
Plan Must Include:
- • Design stages (concept, design, development, validation)
- • Review points and criteria
- • Verification and validation activities
- • Responsibilities and authorities
- • Interfaces between different groups
- • Update procedures
2. Define Design Team
Assign qualified personnel with appropriate skills and experience. Document roles and responsibilities.
- Project manager
- Design engineers (mechanical, electrical, software)
- Quality engineer
- Regulatory affairs specialist
- Clinical specialist
- Manufacturing engineer
3. Establish Review Points
Define when design reviews will occur and what criteria must be met to proceed to next stage.
Typical Review Points:
- • After user needs definition
- • After design inputs are defined
- • After design outputs are complete
- • Before design transfer
- • After design validation
Templates & Documents
Design and Development Plan Template
Word template for design plan
Design Team Roster Template
Excel template for team assignments
Design Review Schedule Template
Excel template for review planning
Design & Development File Index
Plan
Overall design and development plan
Record
List of team members and responsibilities
Plan
Schedule of planned design reviews
Track all design history file documents here. Check off items as you complete them.