CE Technical File Template - TFT
Process and Timeframe
The Technical File Template (TFT) is a tailor made technical file, specific to your device. After the necessary product information is supplied, the TFT can typically be provided within one week from receipt of the order.
The TFT can be summarised as:
- More than 70 protocols, reports and other essential documents needed for CE marking
- All documents are ordered, numbered and formatted
- All documents are specific to your product and company
- All documents contain some content. Some documents are complete!
- A full list of the documents and reports needed to gain the CE mark
- A road map and project plan providing transparency and project status
Achieving the CE mark is essential if you wish to market your device in Europe and other global markets. QMS Consultancy understand the process of CE marking and can help you achieve it faster and with less pain.
We have worked with the Notified Bodies to establish a Technical File Structure that is approved by them and contains all necessary requirements for successful approval. By providing the Technical File in a preferred format, the process of review is simplified for the Notified Body and can often lead to a shorter review time and a faster less expensive route to market.
The TFT we offer is a structured and easy to navigate Technical File containing 20 folders. These folders house over 70 documents that are already numbered, formatted and in most cases, much of the text you will need to write is already included. Where this is not possible to do in advance, examples and helpful text is included in the margin to ensure you know what to include in each section.
Due to the way the TFT is constructed and organised, certain documents that normally take days to complete, (e.g. the Essential Requirements Checklist) can be provided as finished documents that may only need to be signed to complete.
In this manner, the TFT is presented as a bespoke Technical File, specific to your product, company and processes and will be 40-60% complete (dependent on product classification) when you receive it.
As a direct result, the TFT can save you months of administration and report writing, time saved that you can spend developing your product.
Contact us today to see how we might help you!.