CE Mark Product Technical File Submission DIY Toolkit is designs for CE Mar technical file submission and covering CE Mar registration requirement. The CE Mark software has been developed and also being used by our consultants while conducting corporate training sessions and implementation of CE Mark at various client organizations.

Click here to download CE Mark Overview and Product Technical File Demo Kit.

This software has sample technical file which helpful for any organization in preparation of their product technical file. Many clients are already used this software and achieved CE Mark registration.

A) Contents of the CE Mark Toolkit

1. CE Mark Product Technical File included product descriptions, sample process details, product validation reports in Microsoft Word format, total 38 pages.

2. 1 set ESSENTIAL REQUIREMENTS CHECKLIST for technical file in Microsoft Word format.

3. 1 set User Manual and product label for technical file in Microsoft Word format.

4. CE Mark Overview and Implementation in Microsoft Power Point format.

5. Standard “CE” Mark Logo.

1. Software is developed under guidance of experienced CE Mark consultants write in Microsoft Power Point, Word and Excel format.

2. Product Technical File, User Manual and Training Presentation written in Plain English easy to learn and can be edited into your technical file.

3. Good guidance and overview of CE Marking submission requirements.

4. Specifically designed to be very easy to customize into your technical submission file that is required by CE Marking.

1. Software provided guidance and overview training in detail of CE Mark requirements which give user more confidence in preparation of technical file.

2. The user can modify the software to create own Product Technical File for their organization, which can reduce your time in document preparation and cost to engage consultant.

3. Sample CE technical file can be used for preparation of technical file after necessary changes done with the guidelines given in this model technical file.

1. Companies that need CE Mak as a marketing tool to circulate products freely within the EU and achieve registration quickly and easily without consultant.

2. Small to midsize medical device companies to develop Product Technical File.