Technical Documentation
The key to gaining regulatory approval is technical documentation. This documentation, known as a Technical File, incorporates a huge amount of product information and can be extremely time consuming and difficult to put together.
The Technical File consists of the following information regarding your product:
- Declaration of conformity
- A general description of the product
- Design and production drawing and diagrams
- Detailed technical data for essential aspects of the product
- List of standards applied
- Packaging and labelling
Report of tests that have been carried out
- Certificate and inspection reports
- User Manual
How can KD&A help?
To increase efficiency and decrease confusion, KD&A will create a high quality and robust Technical File for your product(s), ensuring that all necessary criteria are covered. Our experience, once again, helps your company with a smooth journey through this aspect of the regulatory process.
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Please contact us for a quotation or to discuss your needs. We look forward to hearing from you.
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