(3) 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 Regulatory Approval
- All documents are ordered, numbered and formatted
- All documents are specific to your product and company
- All documents contain some content. Some documents are nearly complete!
- A full list of the documents and reports needed to gain the Regulatory Approval
- A road map and project plan providing transparency and project status
Achieving Regulatory Approval is essential before selling in all global markets. QMS Consultancy understands the processes needed for many global regions and can help you achieve entry faster and with less pain.
We have establish a Technical File Structure that matches the format expected from the Regulatory Authorities, simplifying the process of review and in many cases leading to a shorter review time and thus a faster less expensive route to market.
The TFT can be structured within different formats to match the requirements of STED, IMDRF, UKCA and CE. This makes the TFT easy to navigate, not only for the companies who purchase them, but also for the regulatory authorities who will ultimately receive them for review on application. These folders house over 70 documents that are already numbered and formatted and 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 in a near ready format and 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.
The Design Workshop is a way to either, kickstart an old project, accelerate a new project or document this part of the product development that may have been missed. All outputs from the workshop are essential parts of a compliant Technical File. The aim of the workshop is to document the Design Inputs, identify the Hazards & initiate a Risk Assessment. All of this is held together and underpinned by a Traceability Matrix which will ensure Design Outputs meet the Design Inputs and provide you with a method to create a Master Validation Plan.
Contact us today to see how we might help you!.