Device Documentation A Guide to Managing Four Critical Production Files
The FDA’s Quality System Regulation requires devicemakers to develop and maintain four files of information related to design, production and overall quality system.
The Device History File, Device Master Record and Device History Record all apply to individual devices. Devicemakers must have these files for every product they manufacture.
The Quality System Record provides information on a devicemaker’s manufacturing operations as a whole, rather than on specific devices.
You need to understand how these files differ and how they fit together, including:
Which phase of development and production generates each file
What information should be included in each file
Which files should be device-specific
How to handle special cases, such as Class I devices, specification developers and UDI requirements
These four types of files create an intricate web of documentation critical to producing quality products and complying with FDA and international regulations.
With Device Documentation: A Guide to Managing Four Critical Production Files you will learn about:
The required elements in the Device Master Record (DMR)
The source of the Device Master Record
The required elements in the Device History Record (DHR)
The linkage between the DMR and the DHR
The relationship between the Device History File (DHF), DMR, and DHR
The role of the Quality System Record (QSR) and ensuring you have one
The effect of UDI on these required records
The changes in ISO 13485:2016 related to these records
BONUS: You’ll receive a checklist for developing the files to make sure you are fully compliant.
Order Device Documentation for a detailed guide that will help you understand each element and their relationships with each other, as well as guidance on how to develop the files.
PDF Edition — $99
Who Will Benefit
Design & Development Managers
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