CE Marking Procedure/Forms (SYS-025, Technical Documentation)

CE Marking CE Marking Procedure/Forms (SYS 025, Technical Documentation)          This procedure package includes four documents

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. 

CE Marking CE Marking Procedure/Forms (SYS 025, Technical Documentation)
CE Marking Procedure/Forms
Price: $299.00

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To review a sample Medical Device Academy procedure click below:

  managment review sample SOP CE Marking Procedure/Forms (SYS 025, Technical Documentation)

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