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.

Other Services
Regulatory Advice
Quality Systems
Export Development Assistance
Business Plans, Strategy and Development

Please contact us for a quotation or to discuss your needs. We look forward to hearing from you.

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