Design documentation. Joe Selva Rohan Thakkar Jean Valderrama. Documentation. “Documentation” is what’s written on paper
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If it isn’t documented, it didn’t happen!
An Executive Summary introducing what will be provided to the customer and how they will benefit from it.
Statement of what a not-yet-designed product is intended to do. To ensure that the subsequent design and development of a product meets the needs of the user.
Provides explicit information on the requirements for a product and how the product is put together.
“Each manufacturer shall establish and maintain a DHF for each type of device. The Device shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approval design plan and the requirements of this part.”
Code of Federal Regulations, Title 21 – Food and Drugs, Chapter I – Food and Drug Administration Department of Health and Human Services, Subchapter H – Medical Devices.
Routine documentation required to manufacture devices that meet the company requirements.
Shows all operations, processes, etc. described in the DMR have been accomplished for the finished device and also includes:
Contains all relevant design data which the product can be demonstrated to satisfy the essential safety requirements which are formulated in the Medical Device Directives.