CE Mark Product Technical File Submission DIY Toolkit is designs for CE Mark technical file submission, it covering CE Mark technical file template and CE mark registration requirements. The CE marking is a European proof of conformity and is also described as "passport" that allows manufacturers and exporters to circulate products freely within the EU. Many clients are already certified using our document toolkit and sample CE Mark technical file.
This CE Mark toolkit has been developed and also being used by our consultants while conducting corporate training sessions. Globally many clients from USA, UK, Middle East, Europe, Asia are already using our documents and ready to use templates and already certified.
The user can modify the toolkit templates as per their products and create CE Mark documents for their organization based on European Union (EU) standard. The sample CE Technical File is helpful for Machine, Pressure, EMC, LVD, Medical device and other directives as well as preparation of CE software. Many clients used this toolkit and achieved CE Mark registration.
Click here to download CE Mark Product Technical File Submission Demo
A) Contents of the CE Mark Toolkit
CE Mark Product Technical File included product descriptions, sample process details, product validation reports in Microsoft Word format, total 38 pages.
1 set ESSENTIAL REQUIREMENTS CHECKLIST for technical file in Microsoft Word format.
1 set User Manual and product label for technical file in Microsoft Word format.
CE Mark Overview and Implementation in Microsoft Power Point format.
Standard “CE” Mark Logo.
B) Features of the CE Mark Toolkit
Software is developed under guidance of experienced CE Mark consultants write in Microsoft Power Point, Word and Excel format.
Product Technical File, User Manual and Training Presentation written in Plain English easy to learn and can be edited into your technical file.
Good guidance and overview of CE Marking submission requirements.
Specifically designed to be very easy to customize into your technical submission file that is required by CE Marking.
C) How this toolkit is useful to you
Software provided guidance and overview training in detail of CE Mark requirements which give user more confidence in preparation of technical file.
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.
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.
D) This toolkit is ideal to you
Companies that need CE Mak as a marketing tool to circulate products freely within the EU and achieve registration quickly and easily without consultant.
Small to midsize medical device companies to develop Product Technical File.
Click here to download a Microsoft Power Point and Word files that containing a CE Mark Overview and Product Technical File Demo Kit.