Here are the items I recommend to be in a DHF. This will assure compliance with FDA and ISO 13485 requirements:
- Product Concept Document (PCD)
- Design Initiation Authorization
- Design and Development Plan
- Risk Analysis
- Design Inputs
- Design Outputs and corresponding approvals
- Design Verification protocols and reports
- Design Validation protocols and reports
- Evidence showing traceability (i.e., trace matrices) between design inputs, outputs, verification, and validation.
- Design Transfer plans and reports
- Design Review meeting minutes and reports
- Design Changes
- Final DHF-audit and design-release authorization
Hope this helps.
------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com------------------------------
Original Message:
Sent: 04-Dec-2017 18:16
From: Rashmi Pillay
Subject: Design History File -checklist
Hi ,
Does anybody have a DHF checklist which can be shared.
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
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