1. Technical Documentation Procedure
Purpose – The purpose of this (8)-page procedure is to establish a process for creating, maintaining, and controlling Technical Files, Design Dossiers and Device Master Records.
Scope – This procedure applies to all of your company’s finished devices and accessories.
2. Essential Requirements Checklist-(includes 6 General Requirements and 35+ Requirements Regarding Design and Construction)
3. Declaration of Conformity Template
4. Technical File Index/Device Master Record Index Template
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
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