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Technical File Approval

A CE Technical File is a comprehensive collection of information and documents that details everything about your product. It is essential to understand how to assemble this information and present the information properly.

As there is no legal requirement for a Notified Body to check or review the technical file, it is the responsibility of the manufacturer to ensure that the equipment is fully compliant, and that they have compiled the technical file accurately and completely. PSA understands however that you may not have the time, resource or compliance knowledge to compile a file on your own, so we can work with you to ensure your product achieves compliance. We review & approve your technical file. Utilising the expertise of our compliance engineers we will ensure that you can feel confident that you have followed the requirements of the directive



 
 
Inviting International Partners | looking for Independent competent auditor for QMS, EMS, OHSAS, FSMS & ESMS, CE-Marking, Medical Device..
 
 
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