Technical File CE Marking

A Technical File is a requisite in obtaining Medical Device CE Marking. The technical File must contain all relevant information about the device to outline the safety, performance and efficiency . QualiMEDtech will assist you in the preparation of the Technical File to meet Notified Body requirements.

What is the difference between Technical File and Design Dossier?

Technical File is mandatory for Technical File CE Marking as per various Directive requirements. Any Medical Device, Invitro Diagonostic Devices or Active Implantable Medical Device Notified Body Certification candidates for a Technical File. Generally Class 11b and Class 111 Technical Files is called as Design Dossier.

How fast we can prepare a Medical Device Technical File?

We are experts and professionals in CE Marking Medical Device Technical File preparation and Notified Body submissions. The time to complete a technical File depends on the following

  • Medical Device Classification
  • Number of variants

Generally, for class 111 medical device CE Marking Technical File / Design Dossier takes on an average 90 days to complete with the complete cooperation of the client/manufacturer. The preparation is much more faster if the client/manufacturer ISO 13485 implementation is strong.

What would be the manufacturer contribution for completing a CE marking technical File?

To successfully prepare a technical file the manufacturers team members got a vital role.

  • Provide product specific test information and quality reports
  • IFU/ User manual
  • Applicable product specific International Standards etc.
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